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Terminated

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

FDA Recall Z-1070-2016 · Posted None

Recalling FirmConforMIS, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-01-28
Date Terminated2016-03-09
Product Quantity1 unit

Reason for Recall

Incorrect femoral component distributed

Firm Action

Conformis notiifed the surgeon via the sales rep on 1/28/16 of the error and the correct femoral component was processed. The surgeon received it on February 1, 2016.

Root Cause

Packaging process control

Distribution Pattern

KY

Official Source

View FDA Recall →

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

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