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Class 2 Device Recall Allen Medical CFlex, Polar Head Positioner Catalog Number A70700A1 |
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| Date Initiated by Firm |
November 27, 2007 |
| Date Posted |
August 20, 2008 |
| Recall Status1 |
Terminated 3 on August 26, 2008 |
| Recall Number |
Z-1478-2008 |
| Recall Event ID |
46781 |
| Product Classification |
Patient Position Support - Product Code CCX
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| Product |
Allen 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 |
Recalling Firm/
Manufacturer |
Allen Medical Systems, Inc.
One Post Office Square
Acton MA 01720
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| For Additional Information Contact |
John Ashby
978-263-5401
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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.
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FDA Determined
Cause 2 |
Device Design |
| Action |
Allen 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 Commerce |
2 |
| Distribution |
MA, MS |
| 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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