Devices

Device Recall BUDDE Halo Neurosurgical Retractor System, Model 40A1040.

Model / Serial
Lot # 031 - etched on the side of the Clamp Assembly
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
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.
Manufacturer
Ohio Medical Instrument Co Inc
1 Event
- Recall of Device Recall BUDDE Halo Neurosurgical Retractor System, Model 40A1040.

Manufacturer

Ohio Medical Instrument Co Inc

Manufacturer Address
Ohio Medical Instrument Co Inc, 4900 Charlemar Dr, Cincinnati OH 45227
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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