Device recall
Z-1514-2018: Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for…
FDA device recall · Class II · Synthes, Inc.
Key facts
| Recall number (Z-number) | Z-1514-2018 |
|---|---|
| Recall event | 79698 |
| Product | Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants. |
| Product code | HWB |
| Recalling firm | Synthes, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2019 |
| FEI number | 3005180112 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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