# FDA recall Z-1263-2024

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2024-02-06.

## Product

NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

## Reason for recall

Potential packaging breaches of inner blister and outer sterile blister.

## Distribution

Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.

## Key facts

- **Recall number:** Z-1263-2024
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-06
- **Report date:** 2024-03-13

- **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-1263-2024

## Citation

> AI Analytics. FDA recall Z-1263-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1263-2024. Source: US FDA. Licensed CC0.

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