Device product
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Z-0957-2026
Product summary
- Event
- Event 98051
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 168 units (US 83; OUS 85)
- Official record key
device-enforcement:Z-0957-2026
Official wording
Reason: Removal of affected lot of screws due to labeling error.
Code information: Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
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.
Derived failure modes
-
Labeling or packaging
labeling error