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Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in p...

FDA Recall #Z-0459-2022 — Class II — November 24, 2021

Recall #Z-0459-2022 Date: November 24, 2021 Classification: Class II Status: Ongoing

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

Recalling Firm

Howmedica Osteonics Corp. — Mahwah, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

7 units

Distribution

US Nationwide distribution in the states of GA, MI, NC, TX.

Code Information

Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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