—#148602

Product

TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K150496
Affected lot / code info: P236112, P239165

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Pl, Memphis, Tennessee 38132-1703

Distribution

Distribution pattern: AR, MN,MA

Timeline

Recall initiated: 2016-07-18
Terminated: 2016-11-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148602. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.