Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Abbott Spine Sequoia dorsal height & revision toolsee related information
Date Initiated by FirmAugust 20, 2009
Date PostedDecember 22, 2009
Recall Status1 Terminated 3 on April 13, 2011
Recall NumberZ-0554-2010
Recall Event ID 52805
510(K)NumberK082032 
Product Classification Surgical instrument for pedicle screw system. - Product Code NKB
ProductZimmer / 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
ActionZimmer 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 Commerce215
DistributionNationwide, Belgium and New Zealand.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NKB
-
-