RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,
FDA Recall Z-2632-2016 · Posted None
Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-07-18
Date Terminated2016-11-22
Product Quantity3
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.