Reported Sep 2, 2020 · Terminated
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL…
Conformis, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Conformis, Inc. · 600 Technology Park Dr · Billerica, MA · 01821-4154
Is this the product you have?
- Conformis iTotal Cruciate Retaining (CR) Knee Replacement
- System- Orthopedic Implant CatTCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
- Lot codes and dates
- Serial Number0469247 Exp. 2021-01-31
- Amount recalled
- 1 kit
Where it was sold
Why it was recalled
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
This product could cause temporary or reversible health problems — stop using it.
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