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Terminated

TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

FDA Recall Z-2637-2016 · Posted None

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-07-18
Date Terminated2016-11-22
Product Quantity2 units

Reason for Recall

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

Firm Action

On 07/18/2016, the firm initiated the correction by verbally notifying (by visit and telephone) three of four (3 of 4) implanting surgeons; the fourth implanting surgeon was verbally notified on 07/25/2016. The firm followed with a letter to all four (4) surgeons on 07/28/2016. Medtronic recommended that the condition of the patients receiving the subject part be assessed for any indications of premature failure during normal post-operative follow-up visits.

Root Cause

Employee error

Distribution Pattern

AR, MN,MA

Official Source

View FDA Recall →

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

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