Device recall
Z-1324-2009: Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in…
FDA device recall · Class II · Synthes Spine
Key facts
| Recall number (Z-number) | Z-1324-2009 |
|---|---|
| Recall event | 51777 |
| Product | Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure components together or as a means of bone distraction/compression. Each side of the Square Nut is etched with a number, 1-2-3-4… |
| Product code | KTT |
| Recalling firm | Synthes Spine |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2009 |
| 510(k) numbers | K051600 |
| FEI number | 3005180112 |
At a glance
- 1–9 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