Device product
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
Z-2778-2020
Product summary
- Firm
- Anjon Holdings
- Event
- Event 85958
- Status
- Terminated
- Classification
- Class II
- Quantity
- 249 devices
- Official record key
device-enforcement:Z-2778-2020
Official wording
Reason: High rate of galling of one threaded component.
Code information: REF number 100048 Lot # 170240, US customer Lot # 170162, 170163, 70164,170165, 170229, 170240, 170247, 170260 and SM 42048. International customers.
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the state of MI and the country of Japan for training purposes.
Derived failure modes
-
Unknown
High rate of galling of one threaded component.