Reported Dec 7, 2016 · Terminated
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for…
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 Cruciate Retaining (CR) Knee Replacement System
- Sterile Catalog NumberTCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device
- Lot codes and dates
- Serial Numbers
03810240381042
- Exp Date2017-02-28
- Serial Numbers
- Amount recalled
- 2 units
Where it was sold
Why it was recalled
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
This product could cause temporary or reversible health problems — stop using it.
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