FDA Recall
Terminated
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.
Recall: Z-0658-2017
·
Initiated October 18, 2016
Recall
- Recall Number
- Z-0658-2017
- Event Number
- 75553
- Firm
- ConforMIS, Inc.
- FEI Number
- 3009844603
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- October 18, 2016
- Terminated
- December 7, 2016
- Address
- 28 Crosby Dr, Bedford, MA, 01730-1402
Description
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.
Reason
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Action
ConforMIS notified the sales representative on 10/18/16 after it became aware of the device mix-up. The sales representative was requested to return any remaining components from iTotal CR kit S/N: 0381042.
Distribution
Distributed to the states of CO and NV.
Quantity
2 units