Recall Z-2157-2008 ยท HWT Template
Stryker Howmedica Osteonics Corp.
Stem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm length Catalog numbers: 5565-T-009, 5565-T-010, 5565-T-011, 5565-T-012, 5565-T-013, 5565-T-014 5565-T-015, 5565-T-016, 5565-T-017, 5565-T-018, 5565-T-019, 5565-T-020 5565-T-021, 5565-T-022, 5565-T-023, 5565-T-024, 5565-T-025 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Used in Revision TKA.
| Date | Aug 23, 2008 (initiated May 14, 2008) |
| Status | Terminated |
| Reason | Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely. |
| Root cause | Process control |
| Action | Urgent Product Recall notification letters were sent to all Stryker Branch/Agency Manager/Quality contacts on May 14, 2008 via Federal Express. The letter requests that consignees examine their inventory and hospital consignment locations to identify the product; and retrieve all affected product lots and return it to their branch or agency warehouse for reconciliation. The letter also states that a Stryker Orthopaedics Customer Service rep should be contacted for alternative products available. |
| Quantity | Catalog Number 5565 T-009 to 025: 2629 US, 238 international: Catalog 5566 T-009 to 025: 2625 US, 239 international |
| Distribution | Worldwide Distribution --- including USA and countries of Australia, Canada, Sweden, Germany, Spain, Portugal, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.