Device recall
Z-0781-03: Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a…
FDA device recall · Class II · Ohio Medical Instrument Co Inc
Key facts
| Recall number (Z-number) | Z-0781-03 |
|---|---|
| Recall event | 25715 |
| Product | Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component. The defective sub-assembly part is the Clamp Assembly (Part #438A1071), which is part of the Halo Bracket Assembly. |
| Product code | GZT |
| Recalling firm | Ohio Medical Instrument Co Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 1, 2003 |
| 510(k) numbers | K830332 |
| FEI number | 1525725 |
At a glance
- 1–9 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