Recall Z-0964-2013 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE
| Date | Mar 18, 2013 (initiated Jan 24, 2013) |
| Status | Terminated |
| Reason | The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed. |
| Root cause | Process design |
| Action | A Notification Letter/Product Accountability Form dated 01/28/2013 was sent via FedEx on 01/28/2013 to the sole US branch receiving the affected devices. The branch was instructed to also contact the hospitals in its territory that have the affected product to arrange return of the product. Affected products to be returned to Stryker Orthopaedics, 325 Corporate Drive, Mahway, NJ 07430. |
| Quantity | 4 units (total of 2 sets) |
| Distribution | 1 Branch (NJ) with one consignee (DE). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053514 | TRIATHLON TOTAL KNEE SYSTEM Stryker Orthopaedics, Jan 26, 2006 |