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U.S. Department of Health and Human Services

Class 2 Device Recall Allen CFlex Head Positioner

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  Class 2 Device Recall Allen CFlex Head Positioner see related information
Date Initiated by Firm November 16, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on November 14, 2012
Recall Number Z-0655-2012
Recall Event ID 60435
Product Classification Support, patient position - Product Code CCX
Product Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery

Catalog Numbers: A-70700 and A-70701-2
Code Information A128573, A157480, A164957, A165624, A179587, A200505, A200508, A203121, A203123, A203124, A203126, A205717, A205730, A205731, A207969, A207970, A207971, A207973, A208274, A208275, A208277, A208278, A208932, A208933, A208934, A209578, A210915, A210916, A210917, A210919, A210920, A214252, A214253, A214254, A214255, A214256, A214582, A214583, A214584, A215498, A215489, A215499, A215500, A216459, A216460, A216461, A217594, A217595, A217596, A217597, A218945, A219496, A219623, A219624, A220031, A220032, A220033, A220664, A220665, A222121, A222122, A222123, A222394, A223961, A223962, A223963, A223964, A224084, A224085, A224144, A224145, A225106, A225107, A225553, A225554, A22555, A225972, A225973, A226214, A226215, A226216, A226217, A226218, A226910
Recalling Firm/
Manufacturer		 Allen Medical Systems, Inc.
One Post Office Square
Acton MA 01720
For Additional Information Contact
978-263-5401
Manufacturer Reason
for Recall		 C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity
FDA Determined
Cause 2		 Process design
Action Allen Medical Systems sent a Urgent Medical Device Recall Notification dated November 18, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Allen Medical will provide packaging materials and instructions for returning your device for repair at not cost to you. Each unit will be repaired and tested. Devices which pass all testing will be returned to the field. For further questions please call 888-521-4277 ext. 4280
Quantity in Commerce 83 units
Distribution Worldwide Distribution -- USA (nationwide ) and the countries of Africa, Australia, Bulgaria, China, Germany, India, Istanbul, France, Greece, New Zealand, Saudi Arabia,Singapore, Spain, Taiwan and Japan.
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.
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