Z-0459-2022 Class II Ongoing
FDA device recall Z-0459-2022 was initiated by Howmedica Osteonics Corp. on November 24, 2021 and is designated Class II. Reason for recall: 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) instru… The recall status is ongoing. Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 12, 2022
- Initiation Date
- November 24, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product 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
Reason for Recall
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
Distribution Pattern
US Nationwide distribution in the states of GA, MI, NC, TX.
Code Information
Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503