Device recall
Z-1798-2009: Medtronic INTREPID Spinal System SPACER M 37X27, 8 DEG, Size 10MM, Part Number…
FDA device recall · Class II · Medtronic Sofamor Danek USA Inc
Key facts
| Recall number (Z-number) | Z-1798-2009 |
|---|---|
| Recall event | 52125 |
| Product | Medtronic INTREPID Spinal System SPACER M 37X27, 8 DEG, Size 10MM, Part Number: REF 7962810; 12MM, REF 7962812; 14MM, REF 7962814; 16MM, REF 7962816; 18MM, REF 7962818; 20MM, REF 7962820; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients… |
| Product code | MAX |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2010 |
| 510(k) numbers | K080083 |
| FEI number | 1000477302 |
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