Z-1478-2008

Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to...

Name: Z-1478-2008 Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to...
Creator: Allen Medical Systems, Inc.
Published: 2007-11-27
License: https://open.fda.gov/license/

Allen Medical Systems, Inc. / initiated 2007-11-27 / Terminated / root cause: design

FDA source

Allen Medical Systems, Inc. began a recall of 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... on 2007-11-27. The reason FDA records is "Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1478-2008
Status: Terminated
Initiated: 2007-11-27
Posted: 2008-08-20
Terminated: 2008-08-26
Recalling firm: Allen Medical Systems, Inc.
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.
Product code: CCX Support, Patient Position
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.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Serial Numbers: A111211, A116292

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)