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Implants & Prosthetics

🏥 Medical Devices • 4,540 recalls

Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for imaging.

Angiodynamics Inc. (Navilyst Medical Inc.)

Class I - Dangerous

AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.

Feb 22, 2021 Implants & Prosthetics Nationwide View Details →

Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP HVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US HVAD DC Adapter Controller: Model Number: 1440 HVAD DATA CABLE 1575- MONITOR, Model Number: 1575 HVAD Battery Pack, Model Numbers: 1650, 1650CA-CLIN, 1650DE HeartWare Patient Pack, Model Number: 1475 HeartWare Waist Pack, Model Numbers: 2050, 2050IL, 2050OUS HeartWare Shoulder Pack, Model Numbers: 2060, 2060IL, 2060OUS The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

Heartware

Class I - Dangerous

Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence issues. The PM is being updated to clarify use of the support strap and wear instructions in addition to cleaning instructions of the carrying cases. The IFU and PM are being updated to add a useful life for the carrying cases. The PM is being updated to inform users to keep the driveline cover on when disconnecting and reconnecting the driveline. The IFU and PM are being updated to clarify the power-up sequence that causes the alarm indicator LEDs and both sets of battery LEDs to turn red for 2.5 seconds while the LCD displays the power-on message. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87603 and 87604

Feb 26, 2021 Implants & Prosthetics Nationwide View Details →

NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 195 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 210 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 225 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 300 mm length; End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; PRECICE Trauma Nail System/Precice Unyte-Tibia Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 300 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 315 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 330 mm length; Orthopedic trauma intra

Nuvasive Specialized Orthopedics

Class I - Dangerous

Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

Feb 12, 2021 Implants & Prosthetics Nationwide View Details →

Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set I-K3834CG1L Specialty Triathlon TS Trial Cutting Guide Size 1 Left I-K3834CG1R Specialty Triathlon TS Trial Cutting Guide Size 1 Right I-K3834CG2L Specialty Triathlon TS Trial Cutting Guide Size 2 Left I-K3834CG2R Specialty Triathlon TS Trial Cutting Guide Size 2 Right I-K3834CG3L Specialty Triathlon TS Trial Cutting Guide Size 3 Left I-K3834CG3R Specialty Triathlon TS Trial Cutting Guide Size 3 Right I-K3834CG4L Specialty Triathlon TS Trial Cutting Guide Size 4 Left I-K3834CG4R Specialty Triathlon TS Trial Cutting Guide Size 4 Right I-K3834CG5L Specialty Triathlon TS Trial Cutting Guide Size 5 Left I-K3834CG5R Specialty Triathlon TS Trial Cutting Guide Size 5 Right I-K3834CG6L Specialty Triathlon TS Trial Cutting Guide Size 6 Left I-K3834CG6R Specialty Triathlon TS Trial Cutting Guide Size 6 Right I-K3834CG7L Specialty Triathlon TS Trial Cutting Guide Size 7 Left I-K3834CG7R Specialty Triathlon TS Trial Cutting Guide Size 7 Right I-K3834CG8L Specialty Triathlon TS Trial Cutting Guide Size 8 Left I-K3834CG8R Specialty Triathlon TS Trial Cutting Guide Size 8 Right

Howmedica Osteonics

Class I - Dangerous

The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery.

Mar 5, 2021 Implants & Prosthetics View Details →

NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/10.7mm,¿ +15mm; Packaged End Cap 8.5/10.7mm,¿ +20mm; Packaged End Cap 12.5mm,¿ +0mm; Packaged End Cap 12.5mm,¿ +5mm; Packaged End Cap 12.5mm,¿ +10mm; Packaged End Cap 12.5mm,¿ +15mm; Packaged End Cap 12.5mm,¿ +20mm; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 4.0 mm X 65 mm Locking Screw, Peg; 4.0 mm X 70 mm Locking Screw, Peg; 4.0 mm X 75 mm Locking Screw, Peg; 4.0 mm X 80 mm Locking Screw, Peg; 4.0 mm X 85 mm Locking Screw, Peg; 4.0 mm X 90 mm Locking Screw, Peg; 4.0 mm X 95 mm Locking Screw, Peg; 4.0 mm X 100 mm Locking Screw, Peg; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; Orthopedic intramedullary limb lengthening rod, residual limb lengthener, 14 mm diameter, 130 mm length; Orthopedic surgical instrument - for use with the intramedullary limb lengthening rod, residual limb lengthener;

Nuvasive Specialized Orthopedics

Class I - Dangerous

Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

Feb 12, 2021 Implants & Prosthetics Nationwide View Details →

NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/10.7mm,¿ +15mm; Packaged End Cap 8.5/10.7mm,¿ +20mm; Packaged End Cap 12.5mm,¿ +0mm; Packaged End Cap 12.5mm,¿ +5mm; Packaged End Cap 12.5mm,¿ +10mm; Packaged End Cap 12.5mm,¿ +15mm; Packaged End Cap 12.5mm,¿ +20mm; 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 4.0 mm X 65 mm Locking Screw, Peg; 4.0 mm X 70 mm Locking Screw, Peg; 4.0 mm X 75 mm Locking Screw, Peg; 4.0 mm X 80 mm Locking Screw, Peg; 4.0 mm X 85 mm Locking Screw, Peg; 4.0 mm X 90 mm Locking Screw, Peg; 4.0 mm X 95 mm Locking Screw, Peg; 4.0 mm X 100 mm Locking Screw, Peg; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; Orthopedic intramedullary limb lengthening rod, retrograde femur 10 degree, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 160 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur trochanteric, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, universal femur, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, retrograde femur, 10 degree, 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening rod, retrograde femur, 10 degree, 10.7 mm diameter, 230 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur (piriformis), 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur (piriformis), 10.7 mm diameter, 230 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 195 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening

Nuvasive Specialized Orthopedics

Class I - Dangerous

Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

Feb 12, 2021 Implants & Prosthetics Nationwide View Details →

Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide cardiac resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Class I - Dangerous

A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

Feb 3, 2021 Implants & Prosthetics Nationwide View Details →

ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

DePuy Orthopaedics

Class I - Dangerous

Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

Feb 22, 2021 Implants & Prosthetics Nationwide View Details →

Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures.

Stryker Sustainability Solutions

Class I - Dangerous

Product was distributed without receiving regulatory clearance.

Jan 19, 2021 Implants & Prosthetics Nationwide View Details →

The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.

DePuy Orthopaedics

Class I - Dangerous

Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

Feb 22, 2021 Implants & Prosthetics Nationwide View Details →

The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.

DePuy Orthopaedics

Class I - Dangerous

Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

Feb 22, 2021 Implants & Prosthetics Nationwide View Details →

Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Class I - Dangerous

A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

Feb 3, 2021 Implants & Prosthetics Nationwide View Details →

Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems. The Trinity Biolox Ceramic heads are packaged in a double peel pouch configuration.

Corin

Class I - Dangerous

The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.

Jan 25, 2021 Implants & Prosthetics Nationwide View Details →

Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems. The Trinity Biolox Ceramic heads are packaged in a double peel pouch configuration.

Corin

Class I - Dangerous

The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.

Jan 25, 2021 Implants & Prosthetics Nationwide View Details →

VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

Biomerieux

Class I - Dangerous

bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK¿ 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK¿ 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).

Jan 28, 2021 Implants & Prosthetics View Details →

VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

Biomerieux

Class I - Dangerous

bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK¿ 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK¿ 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).

Jan 28, 2021 Implants & Prosthetics View Details →

Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.

Medical Components, Inc

Class I - Dangerous

The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.

Jan 13, 2021 Implants & Prosthetics Nationwide View Details →
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