# FDA recall Z-1653-2023

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2023-04-13.

## Product

TRIATHLON X3 TIBIAL BEARING INSERT   CS #3 12MM-Intended for knee replacement  Catalog Number: 5531-G-312-E

## Reason for recall

Mislabeled:Labeled  Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT   CS #3 12MM,  may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT   PS #4 13MM, and vice versa

## Distribution

US Nationwide - Worldwide Distribution:  CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan

## Key facts

- **Recall number:** Z-1653-2023
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-13
- **Report date:** 2023-06-07

- **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-1653-2023

## Citation

> AI Analytics. FDA recall Z-1653-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1653-2023. Source: US FDA. Licensed CC0.

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