Smith & Nephew, Inc. 2025-12-24 Health serious FDA
Health · FDA · Recall #FDA-Z-0957-2026
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. Recall
Issued December 24, 2025 · Smith & Nephew, Inc.
In December 2025, Smith & Nephew, Inc. recalled the BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Removal of affected lot of screws due to labeling error.
What you should do
- 1 Stop using BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Smith & Nephew, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Smith & Nephew, Inc.
- Category
- Health
- Recall date
- December 24, 2025
- Units affected
- Not reported
- Sold at
- 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: Austr
- Recall number
- FDA-Z-0957-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Smith & Nephew, Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.