Z-2778-2020 Class II Terminated
FDA device recall Z-2778-2020 was initiated by Anjon Holdings on June 18, 2020 and is designated Class II. Reason for recall: High rate of galling of one threaded component. The recall status is terminated (terminated November 25, 2020). Affected quantity: 249 devices.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2020
- Initiation Date
- June 18, 2020
- Termination Date
- November 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 249 devices
Product Description
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.
Reason for Recall
High rate of galling of one threaded component.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the state of MI and the country of Japan for training purposes.
Code Information
REF number 100048 Lot # 170240, US customer Lot # 170162, 170163, 70164,170165, 170229, 170240, 170247, 170260 and SM 42048. International customers.