Reported Apr 20, 2022 · Completed
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
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 Ste 3 · Billerica, MA · 01821-4154
Is this the product you have?
- iTotal Identity Posterior Stabilised (PS)
- Knee Replacement System Model NumberTPS-301-1113-020101
- Lot codes and dates
- Serial Number0496242
- UDIM572TPS3011113011
- Amount recalled
- 1 unit
Where it was sold
Why it was recalled
Incorrect tibial base plate implant packaged in kit
This product could cause temporary or reversible health problems — stop using it.
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