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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 firmConformis Inc
ProductConformis 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 recallAddendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide Distribution - US Nationwide and the country of Germany
Recall initiated20120717
Recall numberZ-2222-2012
Categorydevice
StateMA
CountryUnited States

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