# FDA recall Z-0581-2025

> **Smith & Nephew Inc.** · Class II · device recall initiated 2024-10-29.

## Product

BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

## Reason for recall

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

## Distribution

Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.

## Key facts

- **Recall number:** Z-0581-2025
- **Recalling firm:** Smith & Nephew Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-29
- **Report date:** 2024-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0581-2025

## Citation

> AI Analytics. FDA recall Z-0581-2025. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/Z-0581-2025. Source: US FDA. Licensed CC0.

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