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Terminated

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.

FDA Recall Z-1478-2008 · Posted 2008-08-20

Recalling FirmAllen Medical Systems, Inc.
Recall StatusTerminated
Product CodeCCX
Date Initiated2007-11-27
Date Terminated2008-08-26
Product Quantity2

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

MA, MS

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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