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U.S. Department of Health and Human Services

Class 2 Device Recall Spinal Concepts polyaxial screw driver

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  Class 2 Device Recall Spinal Concepts polyaxial screw driver see related information
Date Initiated by Firm December 01, 2005
Date Posted December 10, 2010
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ABBOTT SPINE, INC.
510(K)s with Product Code = KWQ and Original Applicant = SPINAL CONCEPTS, INC.
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