| Date Initiated by Firm | February 26, 2003 |
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| Date Posted | April 25, 2003 |
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| Recall Status1 |
Terminated 3 on December 01, 2003 |
| Recall Number | Z-0781-03 |
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| Recall Event ID |
25715 |
| 510(K)Number | K830332 |
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| 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. |
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| Code Information |
Lot # 031 - etched on the side of the Clamp Assembly |
Recalling Firm/
Manufacturer |
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. |
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FDA Determined
Cause 2 | Other |
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| Action | The firm contacted their accounts by email and telephone on 2/26/2003. |
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| Quantity in Commerce | 43 components |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = GZT
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