FDA Enforcement
Class II
Ongoing
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Recall: Z-0957-2026
·
Reported December 24, 2025
Enforcement
- Recall Number
- Z-0957-2026
- Event ID
- 98051
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Smith & Nephew, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 24, 2025
- Initiation Date
- November 24, 2025
- Classification Date
- December 18, 2025
- Address
- 130 & 120 Forbes Blvd, Mansfield, MA, 02048, United States
Description
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Reason
Removal of affected lot of screws due to labeling error.
Code Info
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.
Quantity
168 units (US 83; OUS 85)