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

FDA device recall Z-0655-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Allen Medical Systems, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

CCX

Quantity affected

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 Ja

Date initiated

2011-11-16

Date posted

2012-01-11

Date terminated

2012-11-14

Location

Acton, MA