Device recall
Z-1274-2014: Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for…
FDA device recall · Class II · Synthes, Inc.
Key facts
| Recall number (Z-number) | Z-1274-2014 |
|---|---|
| Recall event | 67263 |
| Product | Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. |
| Product code | HRS |
| Recalling firm | Synthes, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 10, 2015 |
| 510(k) numbers | K113364 |
| 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