Device product
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.
Z-0658-2017
Product summary
- Firm
- ConforMIS, Inc.
- Event
- Event 75553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0658-2017
Official wording
Reason: Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Code information: Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28
Distribution pattern: Distributed to the states of CO and NV.
Derived failure modes
-
Labeling or packaging
Mislabeled