Recall Z-0781-03 ยท GZT Retractor, Self-Retaining, For Neurosurgery
Ohio Medical Instrument Co Inc
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.
| Date | Apr 25, 2003 (initiated Feb 26, 2003) |
| Status | Terminated |
| Reason | The component was manufactured with an insufficient weld that could break during use. |
| Root cause | Other |
| Action | The firm contacted their accounts by email and telephone on 2/26/2003. |
| Quantity | 43 components |
| Distribution | The units were shipped to domestic consignees in NY, NJ, IL, and FL; and to foreign customers located in Japan, Hong Kong, Korea, Great Britian, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K830332 | BUDDE-HALO RETRACTOR Ohio Medical Instrument Co., Inc., Mar 2, 1983 |