Anjon Bremer Molded Crown — Class II medical device recall Z-2778-2020
Terminated recall by Anjon Holdings, reported 2020-08-19, distributed nationwide. High rate of galling of one threaded component.
| Recall number | Z-2778-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Anjon Holdings, Jacksonville, FL, United States |
| Recall initiated | 2020-06-18 |
| Classified | 2020-08-10 |
| Reported by FDA | 2020-08-19 |
| Terminated | 2020-11-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 249 devices |
| Lot numbers | 170162, 170163, 170165, 170229, 170240, 170247, 170260, 42048, 70164 |
| Model numbers | 100048 |
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 for recall
High rate of galling of one threaded component.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2778-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.