Device recall
Z-0226-2015: Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The…
FDA device recall · Class I · Synthes (USA) Products LLC
Key facts
| Recall number (Z-number) | Z-0226-2015 |
|---|---|
| Recall event | 69603 |
| Product | Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5). |
| Product code | NKB |
| Recalling firm | Synthes (USA) Products LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 10, 2015 |
| 510(k) numbers | K100952 |
| FEI number | 3008812560 |
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