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Terminated

Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.

FDA Recall Z-0581-2015 · Posted 2014-12-11

Recalling FirmConforMIS, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2014-11-19
Date Terminated2015-10-08
Product Quantity1 unit

Reason for Recall

Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting

Firm Action

Conformis notified the consignee by telephone on 11/19/14, about the problem. A sales representative visited the site and retrieved the device.

Root Cause

Labeling mix-ups

Distribution Pattern

Distributed to IN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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