Conformis Inc Recall: Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model
Conformis Inc Recall: Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Conformis Inc; Product: Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M5725060002
| Recalling firm | Conformis Inc |
|---|---|
| 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. |
| Reason for recall | Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US Nationwide and the country of Germany |
| Recall initiated | 20120717 |
| Recall number | Z-2222-2012 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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