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U.S. Department of Health and Human Services

Class 2 Device Recall PathFinder NXT Pivoting Percutaneous Rod Holder

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  Class 2 Device Recall PathFinder NXT Pivoting Percutaneous Rod Holder see related information
Date Initiated by Firm June 05, 2012
Date Posted July 03, 2012
Recall Status1 Terminated 3 on February 14, 2013
Recall Number Z-1933-2012
Recall Event ID 62137
510(K)Number K100845  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product PathFinder NXT Pivoting Percutaneous Rod Holder

This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves, under the fascia. The rod is secured to the holder by tightening a captive set screw against the rod end in the tip of the holder using the set screw driver. After positioning the rod and securing at least one pedicle screw closure top against the implanted rod, the holder is removed from the rod end by loosening the captive set screw with the set screw driver.
Code Information Part number 3564-1; all lots
Recalling Firm/
Manufacturer		 Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
574-372-4807
Manufacturer Reason
for Recall		 Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed the hex mating feature of the set screw was broken and material missing. There were no reports of fragments of the set screw being left in the patient or that there was any patient or user injury, but these events we
FDA Determined
Cause 2		 Device Design
Action The firm, Zimmer Spine, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 5, 2012 to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the notification and ensure they are aware of the content; to immediately remove and discontinue use of Pivoting Percutaneous Rod Holder (part number 3564-1) from Pathfinder NXT instrument sets in their possession and follow the PathFinder NXT Surgical Technique; to notify their Zimmer Spine customer service representative to obtain return authorization; and return the complete Surgeon Contact Certification Form within 10 working days from receipt of notification to ronald.musselman@zimmer.com or Fax to 1-512-258-0995. If you have any questions, call Zimmer Spine Customer Service at 866-774-6368.
Quantity in Commerce 77 units
Distribution Worldwide distribution: USA (nationwide) and countries of: Australia, France and Germany.
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 = ZIMMER SPINE, INC
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