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U.S. Department of Health and Human Services

Class 2 Device Recall BUDDE Halo Neurosurgical Retractor System, Model 40A1040.

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  Class 2 Device Recall BUDDE Halo Neurosurgical Retractor System, Model 40A1040. see related information
Date Initiated by Firm February 26, 2003
Date Posted April 25, 2003
Recall Status1 Terminated 3 on December 01, 2003
Recall Number Z-0781-03
Recall Event ID 25715
510(K)Number k830332  
Product Classification Retractor, Self-Retaining, For Neurosurgery - Product Code GZT
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.
Code Information Lot # 031 - etched on the side of the Clamp Assembly
Recalling Firm/
Ohio Medical Instrument Co Inc
4900 Charlemar Dr
Cincinnati OH 45227
Manufacturer Reason
for Recall
The component was manufactured with an insufficient weld that could break during use.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GZT and Original Applicant = OHIO MEDICAL INSTRUMENT CO., INC.