Biosure HA Screw recall: Labeling Error
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Why was Biosure HA Screw recalled?
Removal of affected lot of screws due to labeling error.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
- Product
- BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 168 units (US 83; OUS 85)
- 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.
- Recall date
- December 24, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)