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Implants & Prosthetics

🏥 Medical Devices • 4,540 recalls

Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies

Zimmer Biomet

Class I - Dangerous

labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.

Dec 16, 2016 Implants & Prosthetics View Details →

SwishTapered Implant

Implant Direct Sybron Manufacturing

Class I - Dangerous

The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.

Dec 12, 2016 Implants & Prosthetics View Details →

Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Item Number: 183108 Description: VAN PS OPEN INTL FEM-RT 65 Item Number: 183110 Description: VAN PS OPEN INTL FEM-RT 67.5 Item Number: 183112 Description: VAN PS OPEN INTL FEM-RT 70 Item Number: 183113 Description: VAN PS OPEN INTL FEM-RT 72.5 Item Number: 183120 Description: VAN PS OPEN INTL FEM-LT 55 Item Number: 183122 Description: VAN PS OPEN INTL FEM-LT 57.5 Item Number: 183124 Description: VAN PS OPEN INTL FEM-LT 60 Item Number: 183126 Description: VAN PS OPEN INTL FEM-LT 62.5 Item Number: 183128 Description: VAN PS OPEN INTL FEM-LT 65 Item Number: 183130 Description: VAN PS OPEN INTL FEM-LT 67.5 Item Number: 183132 Description: VAN PS OPEN INTL FEM-LT 70 Item Number: 183133 Description: VAN PS OPEN INTL FEM-LT 72.5

Zimmer Biomet

Class I - Dangerous

packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.

Jan 4, 2017 Implants & Prosthetics Nationwide View Details →

Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).

Philips Electronics North America

Class I - Dangerous

Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

Dec 1, 2016 Implants & Prosthetics View Details →

Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).

Philips Electronics North America

Class I - Dangerous

Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

Dec 1, 2016 Implants & Prosthetics View Details →

Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).

Philips Electronics North America

Class I - Dangerous

Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

Dec 1, 2016 Implants & Prosthetics View Details →

Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.

Pentax of America

Class I - Dangerous

Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.

Dec 12, 2016 Implants & Prosthetics Nationwide View Details →

Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).

Philips Electronics North America

Class I - Dangerous

Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

Dec 1, 2016 Implants & Prosthetics View Details →

AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

Endologix

Class I - Dangerous

Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

Dec 27, 2016 Implants & Prosthetics Nationwide View Details →

AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

Endologix

Class I - Dangerous

Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

Dec 27, 2016 Implants & Prosthetics Nationwide View Details →

SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.

Bard Access Systems

Class I - Dangerous

Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.

Dec 19, 2016 Implants & Prosthetics Nationwide View Details →

MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc¿ trays per case and 160 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.

Bard Access Systems

Class I - Dangerous

Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.

Dec 19, 2016 Implants & Prosthetics Nationwide View Details →

Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The pouch and carton labels also contain sterilization indicator dots. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement. The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement

Zimmer Biomet

Class I - Dangerous

Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package labeled as a Right was opened it actually contained a Left Bearing.

Dec 6, 2016 Implants & Prosthetics View Details →

Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function

Straumann Manufacturing

Class I - Dangerous

Drills cannot be inserted into handpiece due to tolerance specification not met

Nov 23, 2016 Implants & Prosthetics Nationwide View Details →

Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. 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

Class I - Dangerous

During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active.

Dec 9, 2016 Implants & Prosthetics View Details →

Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function

Straumann Manufacturing

Class I - Dangerous

Drills cannot be inserted into handpiece due to tolerance specification not met

Nov 23, 2016 Implants & Prosthetics Nationwide View Details →
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