Device recall
Z-0662-03: Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a…
FDA device recall · Class II · Medtronic Xomed, Inc.
Key facts
| Recall number (Z-number) | Z-0662-03 |
|---|---|
| Recall event | 25706 |
| Product | Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows: Part Number 31-55631 Oto-Flex carbide 1.0mm Bur; Part Number 31-55632 Oto-Flex carbide 2.3mm Bur; Part Number 31-55642 Oto-Flex… |
| Product code | EQJ |
| Recalling firm | Medtronic Xomed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2012 |
| FEI number | 1045254 |
At a glance
- None 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