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U.S. Department of Health and Human Services

Class 1 Device Recall TI Synex (TM) II Central Body 14mm 19mm

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  Class 1 Device Recall TI Synex (TM) II Central Body 14mm 19mm see related information
Date Initiated by Firm September 14, 2009
Date Posted November 09, 2009
Recall Status1 Terminated 3 on July 09, 2015
Recall Number Z-0108-2010
Recall Event ID 53509
510(K)Number K003836  
Product Classification Spinal vertebral body replacement device - Product Code MQP
Product Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001.

Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.
Code Information Catalog number 04.808.001 - all lots.
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
800-620-7025 Ext. 5433
Manufacturer Reason
for Recall		 loss of device height
FDA Determined
Cause 2		 Device Design
Action Synthes USA issued an "Urgent: Medical Device Recall" letter to hospital accounts, Synthes personal and sales consultants dated September 23, 2009. Users were asked to take inventory, complete and return a Verification form and return all affected product to the firm. For further information regarding the recall, contact Synthes at 1-800-479-6329 or 1-800-620-7025 extension 5453.
Quantity in Commerce 267 units
Distribution Worldwide Distribution -- Including the United States and Canada.
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
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