Z-0655-2012

Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during...

Name: Z-0655-2012 Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during...
Creator: Allen Medical Systems, Inc.
Published: 2011-11-16
License: https://open.fda.gov/license/

Allen Medical Systems, Inc. / initiated 2011-11-16 / Terminated / root cause: manufacturing process

FDA source

Allen Medical Systems, Inc. began a recall of 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 on 2011-11-16. The reason FDA records is "C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0655-2012
Status: Terminated
Initiated: 2011-11-16
Posted: 2012-01-11
Terminated: 2012-11-14
Recalling firm: Allen Medical Systems, Inc.
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
Product code: CCX Support, Patient Position
Reason for recall: C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Product code CCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)