Device recall
Z-0448-2016: Tray Set containing multiple instruments and may contain the flexible bone awl…
FDA device recall · Class II · Aesculap, Inc.
Key facts
| Recall number (Z-number) | Z-0448-2016 |
|---|---|
| Recall event | 72646 |
| Product | Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems… |
| Product code | LRZ |
| Recalling firm | Aesculap, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 8, 2016 |
| FEI number | 2916714 |
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