FDAFDA · Food and drugs·Recall number Z-0957-2026
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Published December 24, 2025 · Recall initiated: November 24, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Removal of affected lot of screws due to labeling error.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- 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.
- Lot
- Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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