# FDA recall Z-1237-2022

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2022-03-30.

## Product

Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600  Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500

## Reason for recall

Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.

## Distribution

Worldwide distribution - US Nationwide in the states of AL, CA, CO, ID, IN, KS, MI, NV, PA, TN, WA, and WV. The countries of UK and Poland.

## Key facts

- **Recall number:** Z-1237-2022
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-30
- **Report date:** 2022-06-15

- **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-1237-2022

## Citation

> AI Analytics. FDA recall Z-1237-2022. Retrieved 2026-05-31 from https://api.ai-analytics.org/recall/Z-1237-2022. Source: US FDA. Licensed CC0.

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