Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BIOSURE HA SCREW Recalled by Smith & Nephew, Inc. Due to Removal of affected lot of screws due to...

Date: November 24, 2025
Company: Smith & Nephew, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smith & Nephew, Inc. directly.

Affected Products

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

Quantity: 168 units (US 83; OUS 85)

Why Was This Recalled?

Removal of affected lot of screws due to labeling error.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Smith & Nephew, Inc.

Smith & Nephew, Inc. has 220 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report