Device product
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.
Z-2222-2012
Product summary
- Firm
- Conformis Inc
- Event
- Event 62576
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1427 units
- Official record key
device-enforcement:Z-2222-2012
Official wording
Reason: Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
Code information: All serial numbers
Distribution pattern: Worldwide Distribution - US Nationwide and the country of Germany
Derived failure modes
-
Unknown
Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique