Class 2 Device Recall Spinal Concepts polyaxial screw driver

• Date Initiated by Firm: December 01, 2005
• Date Posted: December 10, 2010
• Recall Status: Terminated on June 01, 2011
• Recall Number: Z-0603-2011
• Recall Event ID: 54143
• 510(K)Number: K031985 K052247 K052566 K060634
• Product Classification: Appliance, fixation, spinal intervertebral body - Product Code KWQ
• Product: Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01.
• Code Information: Lots 16HU, 18FL, 19GC, 21BS and 29CK.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 574-267-6131
• Manufacturer Reason for Recall: The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 220
• Distribution: Worldwide Distribution, including US.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWQ; 510(K)s with Product Code = KWQ