Z-0781-03

Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the BUDDE Halo...

Name: Z-0781-03 Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the BUDDE Halo...
Creator: Ohio Medical Instrument Co Inc
Published: 2003-02-26
License: https://open.fda.gov/license/

Ohio Medical Instrument Co., Inc. / initiated 2003-02-26 / Terminated / root cause: manufacturing process

FDA source

Ohio Medical Instrument Co Inc began a recall of 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... on 2003-02-26. The reason FDA records is "The component was manufactured with an insufficient weld that could break during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0781-03
Status: Terminated
Initiated: 2003-02-26
Posted: 2003-04-25
Terminated: 2003-12-01
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.
Product code: GZT Retractor, Self-Retaining, For Neurosurgery
Reason for recall: The component was manufactured with an insufficient weld that could break during use.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm contacted their accounts by email and telephone on 2/26/2003.
Quantity in commerce: 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.
Product codes and lots: Lot # 031 - etched on the side of the Clamp Assembly

Product code GZT

K830332Class IIBudde-Halo RetractorOhio Medical Instrument Co., Inc. / cleared 1983-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)