Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 55 of 125
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T
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-1174-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T
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-1165-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
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-1168-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T
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-1153-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
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-1162-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T
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-1169-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T
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-1152-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
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-1160-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T
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-1171-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T
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-1150-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
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-1163-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T
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-1155-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T
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-1164-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T
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-1161-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
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-1175-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T
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-1159-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T
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-1154-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T
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-1151-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
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-1170-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T
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-1157-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
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-1172-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
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-1167-2019 April 24, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T
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-1158-2019 April 24, 2019 Plainsboro, NJ
Integra Limited
Class II Terminated
Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment ...
Reason: Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Z-1091-2019 April 17, 2019 Plainsboro, NJ
ulrich medical USA Inc
Class II Terminated
ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
Reason: Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
Z-1126-2019 April 17, 2019 Chesterfield, MO