Device recall
Z-2778-2020: Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number…
FDA device recall · Class II · Anjon Holdings
Key facts
| Recall number (Z-number) | Z-2778-2020 |
|---|---|
| Recall event | 85958 |
| 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. |
| Product code | JEC |
| Recalling firm | Anjon Holdings |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 25, 2020 |
| 510(k) numbers | K193256 |
| FEI number | 3003346235 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database