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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM

Zimmer Biomet

Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM

Zimmer Biomet

Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →

Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM

Zimmer Biomet

Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →

Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.

Tosoh Bioscience

Class I - Dangerous

This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.

Jun 11, 2017 Other Medical Devices Nationwide View Details →

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM

Zimmer Biomet

Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →

Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM

Zimmer Biomet

Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM

Zimmer Biomet

Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →

bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

Beaver-Visitec International

Class I - Dangerous

The protective shield was retracted, and the blade was exposed.

Nov 3, 2017 Surgical Instruments Nationwide View Details →

MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device

Medtronic Inc., Cardiac Rhythm and Heart Failure

Class I - Dangerous

Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.

Jul 14, 2017 Implants & Prosthetics View Details →

Brilliance iCT - Model 728306 Computed Tomography X-ray systems

Philips Medical Systems (Cleveland)

Class I - Dangerous

Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.

Jul 11, 2017 Other Medical Devices Nationwide View Details →

smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

Smith & Nephew

Class I - Dangerous

Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa

Dec 11, 2017 Other Medical Devices View Details →

Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.

Vyaire Medical

Class I - Dangerous

Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.

Nov 29, 2014 Infusion Pumps Nationwide View Details →

MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician.

Medtronic Inc., Cardiac Rhythm and Heart Failure

Class I - Dangerous

Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.

Jul 14, 2017 Implants & Prosthetics View Details →

Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to continuously monitor human esophageal, rectal, or skin temperature. They are designed to be used with any patient monitoring system designed to accept 400 Series temperature probes.

Measurement Specialties

Class I - Dangerous

The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.

Mar 13, 2017 Diagnostic Equipment Nationwide View Details →

smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

Smith & Nephew

Class I - Dangerous

One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

Nov 29, 2017 Other Medical Devices View Details →