# FDA recall Z-0459-2022

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2021-11-24.

## Product

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

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

## Key facts

- **Recall number:** Z-0459-2022
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-24
- **Report date:** 2022-01-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0459-2022

## Citation

> AI Analytics. FDA recall Z-0459-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0459-2022. Source: US FDA. Licensed CC0.

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