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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Spine Sequoia dorsal height & revision tool

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  Class 2 Device Recall Abbott Spine Sequoia dorsal height & revision tool see related information
Date Initiated by Firm August 20, 2009
Date Posted December 22, 2009
Recall Status1 Terminated 3 on April 13, 2011
Recall Number Z-0554-2010
Recall Event ID 52805
510(K)Number K082032  
Product Classification Surgical instrument for pedicle screw system. - Product Code NKB
Product Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system.
Code Information Lots 47PN, 47PP, 49HK, 49HL and 57WL.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-258-0995
Manufacturer Reason
for Recall		 The tip of the instrument may fracture during use.
FDA Determined
Cause 2		 Device Design
Action Zimmer sent a letter dated 8/17/09 to distributors and consignees on or about 8/20/09. Users were notified of the potential problem via the letter and advised that the instruments will be removed and replaced when a new version of the instrument becomes available (around 10/09).
Quantity in Commerce 215
Distribution Nationwide, Belgium and New Zealand.
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 = NKB and Original Applicant = ABBOTT SPINE, INC.
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