Smith & Nephew BIOSURE HA Screw recalled 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.
From the FDA notice · Read the official notice ↗ · All Smith & Nephew recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 168 units (US 83; OUS 85)
- Illnesses reported
- None reported
- Manufactured in
- 130 & 120 Forbes Blvd, Mansfield, MA, United States
- Classification
- Class II
- Recall number
- Z-0957-2026
In the FDA's words
- Description
- BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. Removal of affected lot of screws due to labeling error. 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. Affected quantity: 168 units (US 83; OUS 85)
- Hazard
- Removal of affected lot of screws due to labeling error.
More from Smith & Nephew
See all- Smith & Nephew EVOS tibia plate recalled for mislabeling
ModerateFDAOct 30, 2026