Device product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Z-2849-2020
Product summary
- Firm
- Conformis, Inc.
- Event
- Event 86174
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 kit
- Official record key
device-enforcement:Z-2849-2020
Official wording
Reason: Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Code information: Serial Number: 0469247 Exp. 2021-01-31
Distribution pattern: NV
Derived failure modes
-
Unknown
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920