FDA Device recall Z-2778-2020
Anjon Bremer Molded Crown. bone fixation fastener for spinal use
- FDA Device
- Class II
- terminated
- Published 2020-08-19
On 2020-08-19 the FDA classified a Class II recall of Anjon Bremer Molded Crown. bone fixation fastener for spinal use by Anjon Holdings, citing high rate of galling of one threaded component.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2778-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-18 |
| Published | 2020-08-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Anjon Holdings |
| Distribution | US |
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.
Reason
High rate of galling of one threaded component.
Identifiers
| code_info | REF number 100048 Lot # 170240, US customer Lot # 170162, 170163, 70164,170165, 170229, 170240, 170247, 170260 and SM 42048. International customers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2778-2020%22
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