Device recall
Z-1439-2021: Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6…
FDA device recall · Class II · Medtronic Sofamor Danek USA, Inc
Key facts
| Recall number (Z-number) | Z-1439-2021 |
|---|---|
| Recall event | 87626 |
| Product | Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous… |
| Product code | MAX |
| Recalling firm | Medtronic Sofamor Danek USA, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 3, 2023 |
| 510(k) numbers | K192018 |
| FEI number | 3003120897 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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