Spinal Concepts polyaxial screw driver, AO, Manufactured by Spinal Concepts, Austin, TX, REF 775-01.
This recall has been terminated (originally issued December 10, 2010).
- Company
- Zimmer Inc.
- Recall Initiated
- December 1, 2005
- Posted
- December 10, 2010
- Terminated
- June 1, 2011
- Recall Number
- Z-0602-2011
- Quantity
- 220
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
Distribution
Worldwide Distribution, including US.
Lot / Code Info
Lots 12XM, 16BT, 18FY, 19GS, 20YQ, 21CB and 25ZP.
Root Cause
Device Design
Action Taken
The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S. For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.
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