Recall Z-0140-2023 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Wright Medical Technology, Inc.
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
| Date | Oct 27, 2022 (initiated Sep 30, 2022) |
| Status | Terminated |
| Reason | The tibial tray lock detail is oversized (larger than specification). |
| Root cause | Device Design |
| Action | Stryker notified consignees on about 09/30/2022, via letter that was hand delivered or sent via email titled, "URGENT: MEDICAL DEVICE RECALL." The letter instructed consignees to check inventory and quarantine any affected product, return the enclosed response form, arrange for the return of affected product and notify all applicable parties of the recall if product was further distributed. |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051023 | TOPEZ TOTAL ANKLE REPLACEMENT Topez Orthopedics, Inc., Nov 15, 2005 |