Device recall
Z-0931-2009: Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number…
FDA device recall · Class II · Synthes Spine
Key facts
| Recall number (Z-number) | Z-0931-2009 |
|---|---|
| Recall event | 50523 |
| Product | Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the… |
| Product code | MAX |
| Recalling firm | Synthes Spine |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2009 |
| 510(k) numbers | K072253 |
| FEI number | 3005180112 |
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