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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

NEODENT CM Intraoral Scanbody, Article Number: 108.139

Instradent USA

Class I - Dangerous

During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned.

Mar 13, 2017 Other Medical Devices View Details →

Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.

Teleflex Medical

Class I - Dangerous

Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.

Mar 29, 2017 Surgical Instruments Nationwide View Details →

INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.

Ace Surgical Supply Co.

Class I - Dangerous

Incorrect device was packaged.

Feb 22, 2017 Implants & Prosthetics Nationwide View Details →

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Smith & Nephew

Class I - Dangerous

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Mar 15, 2017 Other Medical Devices Nationwide View Details →

Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usage: For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic procedures. For use with a minimum peak voltage of 3625V.

COVIDIEN MEDTRONIC

Class I - Dangerous

Customer reports of the device handset continuing to operate after release of the activation button.

Jan 26, 2017 Other Medical Devices Nationwide View Details →

It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part number 0270-0429), is added as part of the kit.

Verathon

Class I - Dangerous

Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).

Mar 3, 2017 Other Medical Devices Nationwide View Details →

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Smith & Nephew

Class I - Dangerous

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Mar 15, 2017 Other Medical Devices Nationwide View Details →

Ferno PROFlexx¿ Model 28Z Chair Cot

Ferno-Washington

Class I - Dangerous

The recall was initiated as a result of the detection of an incorrect nut used in manufacturing.

Mar 8, 2017 Other Medical Devices View Details →

Artis zee, Angiographic x-ray system

Siemens Medical Solutions USA

Class I - Dangerous

Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.

Mar 28, 2017 Other Medical Devices View Details →

various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.

Zimmer Biomet

Class I - Dangerous

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Feb 17, 2017 Implants & Prosthetics Nationwide View Details →

The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 722006; Allura Xper FD20/10 and FD20/20 722008; Allura Xper FD10 722010; Allura Xper FD10/10 722011; Allura Xper FD20 722012; Allura Xper FD20 biplane 722013; Allura Xper FD10 OR Table 722014; Allura Xper FD20 OR Table 722015; Allura Xper FD10/10 OR Table 722019; Allura Xper FD20 Biplane OR Table 722020; Allura Xper FD10 OR Table 722022; Allura Xper FD20 OR Table 722023; Allura Xper FD10/10 OR Table 722024; Allura Xper FD20 Biplane OR Table 722025; Allura CV20 722031

Philips Electronics North America

Class I - Dangerous

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

Mar 22, 2017 Other Medical Devices Nationwide View Details →

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Smith & Nephew

Class I - Dangerous

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Mar 15, 2017 Other Medical Devices Nationwide View Details →

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Smith & Nephew

Class I - Dangerous

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Mar 15, 2017 Other Medical Devices Nationwide View Details →

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Smith & Nephew

Class I - Dangerous

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Mar 15, 2017 Other Medical Devices Nationwide View Details →

D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic

Smith & Nephew

Class I - Dangerous

The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

Mar 9, 2017 Other Medical Devices Nationwide View Details →

various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall E1 Liner Ringloc +3mm Neutral Max-Rom ArComXL Liner Ringloc +3mm Neutral Max-Rom E1 Liner Ringloc +5mm Neutral Max-Rom E1 Liner Ringloc 10 Degree ArCom Liner Ringloc 10 Degree Face Changing ArComXL Liner Ringloc 10 Degree Face Changing E1 Liner RingLoc Bi-Polar Ringloc Hi-Wall ArCom Liner RingLoc Hi-Wall ArComXL Liner RingLoc Hi-Wall E1 Liner Ringloc Neutral Max-Rom ArCom Liner RingLoc Neutral Max-Rom ArComXL Liner RingLoc Neutral Max-Rom E1 Liner Product Usage: For use in hip arthroplasty

Zimmer Biomet

Class I - Dangerous

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Feb 17, 2017 Implants & Prosthetics Nationwide View Details →

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Smith & Nephew

Class I - Dangerous

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Mar 15, 2017 Other Medical Devices Nationwide View Details →

D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic

Smith & Nephew

Class I - Dangerous

The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

Mar 9, 2017 Other Medical Devices Nationwide View Details →

Hemotherm CE, model 400CE, Heater-Cooling Device

Cincinnati Sub-Zero Products

Class I - Dangerous

Improperly rated fuses were used in the manufacture of the device.

Mar 9, 2017 Other Medical Devices Nationwide View Details →

Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), ¿ 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)

Laerdal Medical

Class I - Dangerous

The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.

Jan 8, 2017 Other Medical Devices Nationwide View Details →