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U.S. Department of Health and Human Services

Class 2 Device Recall Allen Medical CFlex, Polar Head Positioner Catalog Number A70700A1

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 Class 2 Device Recall Allen Medical CFlex, Polar Head Positioner Catalog Number A70700A1see related information
Date Initiated by FirmNovember 27, 2007
Date PostedAugust 20, 2008
Recall Status1 Terminated 3 on August 26, 2008
Recall NumberZ-1478-2008
Recall Event ID 46781
Product Classification Patient Position Support - Product Code CCX
ProductAllen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the position of an anesthetized patient during surgery.
Code Information Serial Numbers: A111211, A116292
FEI Number 1221538
Recalling Firm/
Manufacturer		 Allen Medical Systems, Inc.
One Post Office Square
Acton MA 01720
For Additional Information ContactJohn Ashby
978-263-5401
Manufacturer Reason
for Recall		Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury.
FDA Determined
Cause 2		Device Design
ActionAllen Medical notified accounts by telephone on 11/08/07 and the Sales Representative. The Hospitals confirmed that the device would be sent back for evaluation and upgraded.
Quantity in Commerce2
DistributionMA, MS
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.
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