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U.S. Department of Health and Human Services

Class 1 Device Recall SynthesTitanium Polyaxial Reduction Head for Titanium Matrix Spine Screws

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  Class 1 Device Recall SynthesTitanium Polyaxial Reduction Head for Titanium Matrix Spine Screws see related information
Date Initiated by Firm October 23, 2014
Date Posted November 26, 2014
Recall Status1 Terminated 3 on August 10, 2015
Recall Number Z-0226-2015
Recall Event ID 69603
510(K)Number K100952  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System.

Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5).
Code Information Part Number  04.634.002   Lot Number 6816781 
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact Customer Support
610-719-6500
Manufacturer Reason
for Recall		 Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification.
FDA Determined
Cause 2		 Process control
Action DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated October 23, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check inventory and remove affected stock, call Synthes to obtain a Return Authorization for the device, and to return the completed verification section of the response form by fax to (610) 430-7083 or Scan/email: Fieldaction@synthes.com. Customers with questions were instructed to call 610-719-5450.
Quantity in Commerce 24
Distribution Distributed to MI, MT, and CO.
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 = SYNTHES SPINE
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