Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the
FDA device recall Z-1478-2008 · posted 2008-08-20 · Terminated
Recall details
- Recalling firm
- Allen Medical Systems, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- CCX
- Quantity affected
- 2
- Distribution
- MA, MS
- Date initiated
- 2007-11-27
- Date posted
- 2008-08-20
- Date terminated
- 2008-08-26
- Location
- Acton, MA
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