BIOSURE HA SCREW recall (Smith & Nephew, Inc.)
Medical deviceClass IIOngoing
Summary: Smith & Nephew, Inc. is recalling BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.. Reason: Removal of affected lot of screws due to labeling error.
What is being recalled
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Why
Removal of affected lot of screws due to labeling error.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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 named: Alabama, California, Colorado, Florida, Iowa, Illinois, Kentucky, Minnesota, North Carolina, Nebraska, New York, Oklahoma, Tennessee, Texas, Utah)
How to tell if yours is affected
Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0957-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | November 24, 2025 |
| Reported | December 24, 2025 |
| Company | Smith & Nephew, Inc. |
| Company location | Mansfield, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 168 units (US 83; OUS 85) |
More recalls from Smith & Nephew, Inc. · all medical device recalls · recalls from November 2025