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.
FDA Recall Z-0781-03 · Posted 2003-04-25
Recalling FirmOhio Medical Instrument Co Inc
Recall StatusTerminated
Product CodeGZT
Date Initiated2003-02-26
Date Terminated2003-12-01
Product Quantity43 components
Reason for Recall
The component was manufactured with an insufficient weld that could break during use.
Firm Action
The firm contacted their accounts by email and telephone on 2/26/2003.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.