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U.S. Department of Health and Human Services

Class 2 Device Recall Implant Holder for SynFixLR

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  Class 2 Device Recall Implant Holder for SynFixLR see related information
Date Initiated by Firm July 23, 2010
Create Date June 26, 2015
Recall Status1 Terminated 3 on December 18, 2014
Recall Number Z-2583-2010
Recall Event ID 56343
510(K)Number K053508  
Product Classification Spinal vertebral body replacement device - Product Code MQP
Product SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure)

The implant holder is used to place the implant into the vertebral disc space.
Code Information Catolog Number: 03.802.039 - all lot numbers
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a potential risk to the patient.
FDA Determined
Cause 2		 Error in labeling
Action Synthes Spine Hospital sent an ' URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated August 20, 2010 to all customers. The letter described the labeling issue and actions to be taken by the customers. The customers were instructed to review the supplementary labeling provided; contact their Synthes Spine Sales Consultant to arrange for provision of the Holding Forceps (p/n 388.401) prior to each SynFix-LR procedure; and complete and return the enclosed Verification Section form to Synthes via fax at 610-251-9005 or email: FieldAction@Synthes.com. If you have any questions, please call 1-800-620-7025 x 3500 or contact your Synthes Spine Sales Consultant.
Distribution Worldwide Distribution: USA and the countries of Canada, Japan, Switzerland, Australia, Mexico, Malaysia, New Zealand, and Singapore.
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 = MQP and Original Applicant = SYNTHES SPINE CO.LP
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