Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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

U.S. FDA — Device Enforcement · United States · 2012-07-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2222-2012
Date of alert: 2012-07-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Conformis Inc
Product category: device
Product type: Devices

Reported risk: Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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