Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 29 of 125
Aesculap Implant Systems LLC
Class II Terminated
AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
Reason: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Z-1447-2022 July 27, 2022 Center Valley, PA
Aesculap Implant Systems LLC
Class II Terminated
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Reason: Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.
Z-1428-2022 July 27, 2022 Center Valley, PA
Aesculap Implant Systems LLC
Class II Completed
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Reason: Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
Z-1409-2022 July 27, 2022 Center Valley, PA
DePuy Orthopaedics, Inc.
Class II Ongoing
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
Reason: Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing &...
Z-1419-2022 July 27, 2022 Warsaw, IN
Aesculap Implant Systems LLC
Class II Terminated
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Reason: Customized coronal rod benders may deform the implant when used with the spinal system devices.
Z-1406-2022 July 27, 2022 Center Valley, PA
Aesculap Implant Systems LLC
Class II Terminated
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Reason: Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
Z-1383-2022 July 20, 2022 Center Valley, PA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome...
Reason: Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Z-1268-2022 June 22, 2022 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; ...
Reason: Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Z-1267-2022 June 22, 2022 Mounds View, MN
Medtronic Inc
Class I Ongoing
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Reason: The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap ma...
Z-1207-2022 June 15, 2022 Minneapolis, MN
Encore Medical, LP
Class II Ongoing
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Reason: A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
Z-1257-2022 June 15, 2022 Austin, TX
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to...
Reason: The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
Z-1206-2022 June 8, 2022 Mounds View, MN
Medtronic Neuromodulation
Class II Ongoing
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
Reason: The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
Z-1123-2022 June 1, 2022 Minneapolis, MN
Medtronic Neuromodulation
Class II Ongoing
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Reason: The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Z-1128-2022 June 1, 2022 Minneapolis, MN
Medtronic Neuromodulation
Class II Ongoing
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Reason: The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Z-1129-2022 June 1, 2022 Minneapolis, MN
Heartware, Inc.
Class II Ongoing
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Reason: Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Vent...
Z-1102-2022 May 25, 2022 Miami Lakes, FL
Medtronic Inc
Class II Ongoing
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models:...
Reason: Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Devi...
Z-1110-2022 May 25, 2022 Minneapolis, MN
Synthes (USA) Products LLC
Class II Ongoing
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diamet...
Reason: DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyeliti...
Z-1072-2022 May 18, 2022 West Chester, PA
Boston Scientific Corporation
Class II Ongoing
SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose deliver...
Reason: Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions ...
Z-1003-2022 May 4, 2022 Marlborough, MA
Boston Scientific Corporation
Class II Ongoing
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiati...
Reason: Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions ...
Z-1002-2022 May 4, 2022 Marlborough, MA
Stryker GmbH
Class II Ongoing
Smart Toe II Intramedullary Arthrodesis Implant
Reason: The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead...
Z-1011-2022 May 4, 2022 Selzach
St. Jude Medical, Cardiac Rhythm Management Division
Class II Ongoing
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Reason: Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The B...
Z-0989-2022 April 27, 2022 Sylmar, CA
St. Jude Medical, Cardiac Rhythm Management Division
Class II Ongoing
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Reason: Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The B...
Z-0990-2022 April 27, 2022 Sylmar, CA
Medtronic Inc
Class I Ongoing
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Reason: There is potential for the capsule bond to break during the procedure.
Z-0927-2022 April 27, 2022 Minneapolis, MN
St. Jude Medical, Cardiac Rhythm Management Division
Class II Ongoing
Merlin 2 PCS MER3700 programmer Model MER3400 software
Reason: Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchroniza...
Z-0965-2022 April 27, 2022 Sylmar, CA
St. Jude Medical, Cardiac Rhythm Management Division
Class II Ongoing
Merlin PCS 3650 programmer Model 3330 software
Reason: Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchroniza...
Z-0964-2022 April 27, 2022 Sylmar, CA