Recall Z-0852-03 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics
Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 8mm Lft.
| Date | May 21, 2003 (initiated Jan 23, 2003) |
| Status | Terminated |
| Reason | The device is demonstrating early wear and delamination. |
| Root cause | Other |
| Action | Recall letters were sent to the Howmedica branches and hospitals on January 23, 2003 via FedEx. |
| Quantity | 1 |
| Distribution | Howmedica distributed this device to 2 Howmedica branches and 3 hospitals are Parkview Episcopal Hospital, Pueblo, CO; St. Mary Corwin Hospital, Pueblo, CO; and Hement Valley Hospital, Riverside, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973121 | INTERAX TOTAL KNEE SYSTEM Howmedica Corp., Nov 18, 1997 |