Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0459-2022 — 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). Catal

U.S. FDA — Device Enforcement · United States · 2021-11-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0459-2022
Date of alert: 2021-11-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Howmedica Osteonics Corp.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 07613327461503

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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