Reported Dec 17, 2014 · Terminated
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee…
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. · 28 Crosby Dr · Bedford, MA · 01730-1402
Is this the product you have?
- Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
- Lot codes and dates
- Serial Number0340552
- Amount recalled
- 1 unit
Where it was sold
Why it was recalled
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
This product could cause temporary or reversible health problems — stop using it.
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