FDA Medical devices recall ·
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener recall
- Recall number
- Z-0957-2026
- Date
- (initiated November 24, 2025)
- Company / brand
- Smith & Nephew, Inc.
130 & 120 Forbes Blvd, Mansfield, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 168 units (US 83; OUS 85)
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Why was it recalled?
Removal of affected lot of screws due to labeling error.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
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.
States: Alabama California Colorado Florida Iowa Illinois Kentucky Minnesota North Carolina Nebraska New York Oklahoma Tennessee Texas Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0957-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.