Howmedica Osteonics Corp. Recall 89190
Description: 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
Howmedica Osteonics Corp. Recall 89190 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0459-2022 |
| Event ID | 89190 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of GA, MI, NC, TX. |
| Quantity | 7 units |
| Recall 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 |
| Device Classification | 20220112 |
| Device Code Info | Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503 |
| Center Classification Date | 20220106 |
| Recall Initiation Date | 20211124 |
| Recalling Firm | Howmedica Osteonics Corp. |
| Initial Notification | Letter |
| Similar To |