FDA-Device2025-12-24Class IIMISBRANDING
Smith & Nephew BIOSURE HA Screw recalled for labeling error
LABEL MIX UPNationwide distribution
Check Smith & Nephew bone screws for labeling error
Smith & Nephew is recalling certain BIOSURE HA Screws (6mm x 20mm bone fixation screws) due to a labeling error on affected units. The screws themselves are safe, but the packaging labels on a small number of units contain incorrect information. No injuries have been reported.
- If you have these screws in your facility, check the batch numbers: 51315219 or 51306803
- Verify the model numbers match 72201768 or 72204389
- Contact Smith & Nephew if you have affected units for guidance on replacement or return
- Do not use screws from affected batches until you confirm the correct labeling
Hazard
Removal of affected lot of screws due to labeling error.
Sold states
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.
Affected count
168 units (US 83; OUS 85)
Manufactured in
130 & 120 Forbes Blvd, Mansfield, MA, United States
Products
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0957-2026Don't want to check this manually?
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