Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in p...
FDA Device Recall #Z-0459-2022 — Class II — November 24, 2021
Recall Summary
| Recall Number | Z-0459-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 24, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Howmedica Osteonics Corp. |
| Location | Mahwah, NJ |
| Product Type | Devices |
| 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.
Lot / Code Information
Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503
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|---|---|---|---|
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| Z-2640-2025 | Class II | 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Num... | Aug 28, 2025 |
| Z-0023-2025 | Class II | Triathlon Universal TS Baseplate Size 2 - A sin... | Sep 4, 2024 |
| Z-0044-2025 | Class II | MAKO Integrated Cutting System (MICS) HANDPIECE... | Aug 7, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.