FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0781-03
- Recalling firm
- Ohio Medical Instrument Co Inc
- 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.
- Status
- Terminated
- Initiated
- 2003-02-26
- Posted
- 2003-04-25
- Terminated
- 2003-12-01
- 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.
- Lot, serial or model codes
- Lot # 031 - etched on the side of the Clamp Assembly
- 510(k) numbers
- ["K830332"]
- PMA numbers
- not on file
- Product code
- GZT
- Firm FEI
- 1525725
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28