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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 FHCsee related information
Date Initiated by FirmMarch 14, 2005
Date PostedJune 16, 2005
Recall Status1 Terminated 3 on July 08, 2008
Recall NumberZ-0895-05
Recall Event ID 31718
510(K)NumberK003776 K011775 K011992 
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
ProductFHC 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 ContactKeri Seitz
207-666-8190
Manufacturer Reason
for Recall
Potential for non-sterile pin to contaminate sterile field
FDA Determined
Cause 2
Other
ActionFHC 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 Commerce169 units
DistributionNatiowide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HAW
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