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U.S. Department of Health and Human Services

Class 2 Device Recall FHC

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  Class 2 Device Recall FHC see related information
Date Initiated by Firm March 14, 2005
Date Posted June 16, 2005
Recall Status1 Terminated 3 on July 08, 2008
Recall Number Z-0895-05
Recall Event ID 31718
510(K)Number k003776  k011992  k011775  
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
Product FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning
Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)
Code Information All codes
Recalling Firm/
Manufacturer		 FHC, Inc.
9 Main St
Bowdoinham ME 04008-4418
For Additional Information Contact Keri Seitz
207-666-8190
Manufacturer Reason
for Recall		 Potential for non-sterile pin to contaminate sterile field
FDA Determined
Cause 2		 Other
Action FHC notified customers by letter dated 3/14/05 and 3/25/05. The firm has issued a temporary set of instructions which include covering the non-sterile engagement pin with sterile tape and an amended Instruction For Use page to all customers. A redesigned pulley cover which will be sent to all customer when it becomes available in April 2005.
Quantity in Commerce 169 units
Distribution Natiowide
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 = HAW and Original Applicant = FHC, INC.
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