Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 74 of 125
Cardinal Health 200, LLC
Class II Terminated
Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining d...
Reason: The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylen...
Z-3107-2017 September 13, 2017 Waukegan, IL
CryoLife, Inc.
Class II Terminated
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position ...
Reason: Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
Z-3108-2017 September 13, 2017 Kennesaw, GA
Stanmore Implants Worldwide Ltd.
Class II Terminated
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
Reason: Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device,...
Z-3104-2017 September 13, 2017 Borehamwood, N/A
Smith & Nephew, Inc.
Class II Terminated
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem i...
Reason: The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Z-3100-2017 September 6, 2017 Memphis, TN
Medtronic Neuromodulation
Class II Terminated
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessorie...
Reason: Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in DBS lead placement beyond the intended target.
Z-3069-2017 August 30, 2017 Minneapolis, MN
Exactech, Inc.
Class II Terminated
Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these inst...
Reason: The Truliant Tibial Trial Handle's pin may disassociate from the main body.
Z-3018-2017 August 23, 2017 Gainesville, FL
Boston Scientific Corporation
Class II Terminated
EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-thr...
Reason: The device can deliver an atypical amount of energy due to memory corruption inside the device.
Z-3038-2017 August 23, 2017 Saint Paul, MN
Boston Scientific Corporation
Class II Terminated
EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threate...
Reason: The device can deliver an atypical amount of energy due to memory corruption inside the device.
Z-3037-2017 August 23, 2017 Saint Paul, MN
In2Bones, SAS
Class II Terminated
Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST01...
Reason: The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis
Z-2869-2017 August 9, 2017 Ecully, N/A
Flowonix Medical, Inc.
Class II Terminated
PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling...
Reason: Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra I...
Z-2740-2017 July 26, 2017 Mount Olive, NJ
St. Jude Medical, Inc.
Class II Terminated
Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by...
Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Z-2693-2017 July 19, 2017 Plano, TX
St. Jude Medical, Inc.
Class II Terminated
Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a...
Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Z-2694-2017 July 19, 2017 Plano, TX
St. Jude Medical, Inc.
Class II Terminated
Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one o...
Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Z-2692-2017 July 19, 2017 Plano, TX
St. Jude Medical, Inc.
Class II Terminated
Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one o...
Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Z-2691-2017 July 19, 2017 Plano, TX
St. Jude Medical, Inc.
Class II Terminated
Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a...
Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Z-2696-2017 July 19, 2017 Plano, TX
St. Jude Medical, Inc.
Class II Terminated
Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a...
Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Z-2695-2017 July 19, 2017 Plano, TX
Exactech, Inc.
Class II Terminated
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifica...
Reason: The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to in...
Z-2644-2017 July 5, 2017 Gainesville, FL
Zimmer Biomet, Inc.
Class II Terminated
Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2567-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2565-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2581-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBI...
Reason: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
Z-2597-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
Reason: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
Z-2599-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Por fullct fem st 17x200mm, Sterile,
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2579-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
Reason: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
Z-2593-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2562-2017 June 21, 2017 Warsaw, IN