Drug recall
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number…
FDA recall event 87626 · Class II · Medtronic Sofamor Danek USA, Inc
Key facts
| Event ID | 87626 |
|---|---|
| Recall numbers | Z-1439-2021, Z-1440-2021 |
| Recalling firm | Medtronic Sofamor Danek USA, Inc |
| Product type | Devices |
| Products | Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device. |
| Initiation date | Mar 17, 2021 |
| Report date | Apr 28, 2021 |
| Termination date | May 3, 2023 |
| City | Memphis |
| State | TN |
| Country | United States |
| FEI number | 3003120897 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: