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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Spine Click X Pedicle Screw

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 Class 2 Recall
Synthes Spine Click X Pedicle Screw
see related information
Date Posted March 11, 2013
Recall Status1 Open
Recall Number Z-0938-2013
Recall Event ID 64173
Premarket Notification
510(K) Number
K992739 
Product Classification Orthosis, Spondylolisthesis Spinal Fixation - Product Code MNH
Product Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
Code Information Lot Number 7542279
Recalling Firm/
Manufacturer
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Manufacturer Reason
for Recall
Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.
FDA Determined
Cause 2
DESIGN: Process Design
Action The firm initiated a recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter, dated January 11, 2013, to all consignees. The letter identified the affected product and the issue, as well as requested that consignees examine their inventory for the product(s) with the identified Part and Lot Numbers, remove them from use, and return them to Synthes. Customers were to follow the steps provided in the letter regarding if they had or did not have any of the identified affected product. Questions were to be directed to 610-719-5450 or Fieldaction@synthes.com.
Quantity in Commerce 18
Distribution Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MNH and Original Applicant = SYNTHES SPINE
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