Halo Support Bracket Assembly (Part #438-B1010). The… recallZ-0781-03 · Ohio Medical Instrument Co Inc · initiated Feb 26, 2003
Terminated All recalls posted in April 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ohio Medical Instrument Co Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The component was manufactured with an insufficient weld that could break during use.
FDA root cause category: Other
What the company is doing
The firm contacted their accounts by email and telephone on 2/26/2003.
Recall details
- Recall number
- Z-0781-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 26, 2003
- Posted by the FDA
- Apr 25, 2003
- Recalling firm
- Ohio Medical Instrument Co Inc
- Quantity
- 43 components
- Product code
- GZT
- FDA submissions
- K830332
- 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.
Product description
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.
Code information (models, lots, serial numbers)
Lot # 031 - etched on the side of the Clamp Assembly
Other devices under the same FDA submission
1 device cleared under K830332 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Budde® A1040Integra Lifesciences Corporation · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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