Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
- Company
- Conformis, Inc.
- Recall Initiated
- July 20, 2020
- Terminated
- June 21, 2021
- Recall Number
- Z-2849-2020
- Quantity
- 1 kit
- Firm Location
- Billerica, MA
Reason for Recall
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Distribution
NV
Lot / Code Info
Serial Number: 0469247 Exp. 2021-01-31
Root Cause
Packaging process control
Action Taken
Conformis notification to field sales representative on July 20,2020 to remove product from use.
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