Device recall
Z-0050-2007: Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured…
FDA device recall · Class II · Medtronic Sofamor Danek Instrument Manufacturing
Key facts
| Recall number (Z-number) | Z-0050-2007 |
|---|---|
| Recall event | 36123 |
| Product | Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic). |
| Product code | HTO |
| Recalling firm | Medtronic Sofamor Danek Instrument Manufacturing |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 4, 2007 |
| FEI number | 3004564008 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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