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Terminated

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

FDA Recall Z-0655-2012 · Posted 2012-01-11

Recalling FirmAllen Medical Systems, Inc.
Recall StatusTerminated
Product CodeCCX
Date Initiated2011-11-16
Date Terminated2012-11-14
Product Quantity83 units

Reason for Recall

C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity

Firm 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

Root Cause

Process design

Distribution Pattern

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.

Official Source

View FDA Recall →

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

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