Device recall
Z-0167-2016: 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular…
FDA device recall · Class II · Synthes (USA) Products LLC
Key facts
| Recall number (Z-number) | Z-0167-2016 |
|---|---|
| Recall event | 72345 |
| Product | 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. |
| Product code | HRS |
| Recalling firm | Synthes (USA) Products LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 15, 2016 |
| 510(k) numbers | K063049 |
| 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