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U.S. Department of Health and Human Services

Class 3 Device Recall Abbott Spine Thoracolumbar Common

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  Class 3 Device Recall Abbott Spine Thoracolumbar Common see related information
Date Initiated by Firm September 21, 2009
Date Posted December 14, 2009
Recall Status1 Terminated 3 on October 08, 2010
Recall Number Z-0525-2010
Recall Event ID 53454
510(K)Number K002082  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1302-55M. Note: This lot was not distributed in the United States.

The component is used in the stabilization of constructs in the BacFix and InCompass spinal fixation systems. It is used within a temporary construct that assists normal healing and is not intended to replace normal body structures.
Code Information Lot 55QJ.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
905-858-8588
Manufacturer Reason
for Recall		 The titanium stock used to manufacturer the product is reported to exhibit areas of alloy segregation, which could result in a weakening of the strength of the metal.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified by letter dated September 21, 2009 and instructed to return the affected product to Zimmer, Inc.
Quantity in Commerce 13
Distribution Worldwide Distribution -- Canada, Mexico and South Africa. (Product not distributed in the United States)
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 = KWP and Original Applicant = SPINAL CONCEPTS, INC.
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