Date Initiated by Firm |
September 14, 2009 |
Date Posted |
November 09, 2009 |
Recall Status1 |
Terminated 3 on July 09, 2015 |
Recall Number |
Z-0116-2010 |
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 71mm - 97mm, Catalog number 04.808.009.
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 04.808.009 - 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 |
76 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
|