# FDA recall Z-0957-2026

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2025-11-24.

## Product

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

## Reason for recall

Removal of affected lot of screws due to labeling error.

## Distribution

US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN, NC, NE, NY, OK, TN, TX, UT; OUS (Foreign) to countries of: Australia, Czech Republic, Finland, France, Germany, Indonesia, Italy, Malaysia, Martinique, Mexico, Netherlands, Norway, Poland, Singapore, Switzerland.

## Key facts

- **Recall number:** Z-0957-2026
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-24
- **Report date:** 2025-12-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0957-2026

## Citation

> AI Analytics. FDA recall Z-0957-2026. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0957-2026. Source: US FDA. Licensed CC0.

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