Recall Z-0459-2022 ยท FSM Tray, Surgical, Instrument
Howmedica Osteonics Corp.
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109
| Date | Nov 24, 2021 |
| Status | Open, Classified |
| Reason | Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation |
| Root cause | Under Investigation by firm |
| Action | Stryker issued an Urgent Medical Device Recall (UMDR) PFA 2799625 issued on Wednesday, November 24, 2021 to all affected U.S. consignees and Stryker Branches by a third-party recall company via UPS 2-day air. Letter states reason for recall, health risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Discontinue use of the recalled Triathlo |
| Quantity | 7 units |
| Distribution | US Nationwide distribution in the states of GA, MI, NC, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.