Recall Z-2635-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Medtronic Sofamor Danek USA Inc
TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
| Date | Jul 18, 2016 |
| Status | Terminated |
| Reason | The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. |
| Root cause | Employee error |
| 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. |
| Quantity | 3 units |
| Distribution | AR, MN,MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150496 | Total Knee Arthroplasty System Responsive Orthopedics, LLC, Jun 12, 2015 |