Recall Z-0655-2012 ยท CCX Support, Patient Position
Allen Medical Systems, Inc.
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
| Date | Jan 11, 2012 (initiated Nov 16, 2011) |
| Status | Terminated |
| Reason | C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.