Z-0957-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2025
- Initiation Date
- November 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 168 units (US 83; OUS 85)
Product Description
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Reason for Recall
Removal of affected lot of screws due to labeling error.
Distribution Pattern
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.
Code Information
Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.