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.
This recall has been terminated (originally issued April 25, 2003).
- Company
- Ohio Medical Instrument Co Inc
- Recall Initiated
- February 26, 2003
- Posted
- April 25, 2003
- Terminated
- December 1, 2003
- Recall Number
- Z-0781-03
- Quantity
- 43 components
- Firm Location
- Cincinnati, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The component was manufactured with an insufficient weld that could break during use.
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.
Lot / Code Info
Lot # 031 - etched on the side of the Clamp Assembly
Root Cause
Other
Action Taken
The firm contacted their accounts by email and telephone on 2/26/2003.