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U.S. Department of Health and Human Services

Class 2 Device Recall PathFinder end screw extender sleeve.

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  Class 2 Device Recall PathFinder end screw extender sleeve. see related information
Date Initiated by Firm April 13, 2010
Date Posted October 18, 2010
Recall Status1 Terminated 3 on February 10, 2012
Recall Number Z-0075-2011
Recall Event ID 54550
510(K)Number K030625  K071174  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior to 2008) and Zimmer Spine Austin TX (7/2009 to present)
Code Information 20XH, 21SM, 25WG, 29CS, 29YL, 31TL, 32SQ, 33ZK, 34LG, 34XW, 35JW, 36WE, 39BH, 43MP, 44WR, 47EX, 48GF, 48LM, 48MB, 50GD and 50GE.
Recalling Firm/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact S. Dale Miller
Manufacturer Reason
for Recall
The tip of the PathFinder End Screw Extender Sleeve has fractured during use. In some cases, this instrument fracture led to surgical delay or additional surgical steps necessary to remove the fragments of the broken tip.
FDA Determined
Cause 2
Device Design
Action Zimmer Spine issued an "Urgent Medical Device Correction" letter through the Zimmer Spine sales force to be provided to PathFinder system users in February 2010. the letter identified the affected product, safety issue, and actions to be taken by customers. Customers will receive replacement devices with a design change for the recalled devices, as they are available from the manufacturer.
Quantity in Commerce 1471 (888 subject to removal)
Distribution Worldwide Distribution: USA including states of AZ, CA, CO, FL, GA, LA, MI, MN, MO, NC, NH, NY, OH, OK, PA, TN, TX, WA, and WI, and the countries of Australia, Belgium, Brazil, Canada, China, Colombia, Cyprus, France, Germany, Greece, Italy, Japan, Mexico, Thailand, Turkey, UK and Switzerland.
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.
510(K)s with Product Code = NKB and Original Applicant = SPINAL CONCEPTS, INC.