Reported Aug 29, 2012 · Terminated
Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left 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 · 1 North Ave · Burlington, MA · 01803-3305
Is this the product you have?
- Conformis iTotal CR-Cruciate Retaining
- Knee Replacement System Model Numbers
M57250600010 iTotal CRLeft Knee M57250600020 iTotal CR
- Right Knee Product UsageUsage: The iTotal CR Knee Replacement System (KRS) is 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 that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis
- Lot codes and dates
- All serial numbers
- Amount recalled
- 1427 units
Where it was sold
- Nationwide
Why it was recalled
Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
This product could cause temporary or reversible health problems — stop using it.
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