Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 54 of 125
MED-EL Elektromedizinische Gereate, Gmbh
Class II Terminated
MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEX...
Reason: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Z-2136-2019 August 14, 2019 Innsbruck, N/A
St Jude Medical Inc.
Class I Terminated
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely in...
Z-2070-2019 August 14, 2019 Sylmar, CA
St Jude Medical Inc.
Class I Terminated
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely in...
Z-2075-2019 August 14, 2019 Sylmar, CA
St Jude Medical Inc.
Class I Terminated
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely in...
Z-2071-2019 August 14, 2019 Sylmar, CA
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRON...
Reason: Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement proc...
Z-2080-2019 July 31, 2019 Tempe, AZ
Clariance Inc
Class III Terminated
Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriv...
Reason: Potential for the polyaxial screw to become disassembled during implant.
Z-1986-2019 July 24, 2019 Chicago, IL
Zimmer Biomet, Inc.
Class II Terminated
DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
Reason: There is a potential for weak seals of the sterile packaging.
Z-1946-2019 July 10, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
Reason: There is a potential for weak seals of the sterile packaging.
Z-1947-2019 July 10, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
Reason: There is a potential for weak seals of the sterile packaging.
Z-1948-2019 July 10, 2019 Warsaw, IN
Conformis, Inc.
Class II Terminated
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Reason: Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
Z-1775-2019 June 19, 2019 Billerica, MA
Conformis, Inc.
Class II Terminated
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Reason: Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
Z-1776-2019 June 19, 2019 Billerica, MA
OMNIlife science Inc.
Class II Terminated
OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock C...
Reason: The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
Z-1717-2019 June 12, 2019 Raynham, MA
I.T.S. GmbH
Class II Ongoing
Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has ...
Reason: The titanium implant has the wrong article number laser marked on it.
Z-1718-2019 June 12, 2019 Lasnitzhohe
Abbott Vascular
Class II Terminated
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Reason: Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantat...
Z-1687-2019 June 5, 2019 Temecula, CA
Collagen Matrix, Inc.
Class II Terminated
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery...
Reason: Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Z-1389-2019 May 29, 2019 Allendale, NJ
Thommen Medical AG
Class II Terminated
Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve ¿ 4.8 mm is used to transfe...
Reason: Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when being inserted into the implant may make it difficult to remove the a...
Z-1390-2019 May 29, 2019 Bettlach, N/A
DePuy Spine, Inc.
Class II Terminated
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
Reason: A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Z-1225-2019 May 8, 2019 Raynham, MA
Matrix Surgical Holdings, LLC
Class II Terminated
OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial r...
Reason: Product mislabeling.
Z-1224-2019 May 8, 2019 Atlanta, GA
Matrix Surgical Holdings, LLC
Class II Terminated
OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial r...
Reason: Product mislabeling.
Z-1223-2019 May 8, 2019 Atlanta, GA
DePuy Spine, Inc.
Class II Terminated
Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
Reason: A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Z-1226-2019 May 8, 2019 Raynham, MA
TriMed Inc.
Class II Terminated
TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. ...
Reason: The bone screw is shorter than the intended design specification.
Z-1214-2019 May 1, 2019 Santa Clarita, CA
Thoratec Corp.
Class II Terminated
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is inten...
Reason: Small black plastic particle was observed in the left ventricle during implant procedure.
Z-1203-2019 May 1, 2019 Pleasanton, CA
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
Reason: The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and...
Z-1166-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T
Reason: The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and...
Z-1156-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
Reason: The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and...
Z-1173-2019 April 24, 2019 Plainsboro, NJ