FDAFDA · Food and drugs·Recall number Z-2222-2012
Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: 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.
Published August 29, 2012 · Recall initiated: July 17, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Conformis Inc
- Distributor
- Worldwide Distribution - US Nationwide and the country of Germany
- Lot
- All serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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