FDA Device

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.

Hazard

The component was manufactured with an insufficient weld that could break during use.

What You Should Do

Remedy

The firm contacted their accounts by email and telephone on 2/26/2003.

Products

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
Brand
Ohio Medical Instrument Co Inc
UPC
Lot # 031 - etched on the side of the Clamp Assembly

Units Affected

43 components