| Class 2 Device Recall Endo TCS Driver Straight Hexalobe 6 P/N 52101004, | |
Date Initiated by Firm | February 20, 2015 |
Date Posted | March 26, 2015 |
Recall Status1 |
Terminated 3 on April 17, 2015 |
Recall Number | Z-1324-2015 |
Recall Event ID |
70576 |
510(K)Number | K142940 |
Product Classification |
Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
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Product | Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC.
Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD). |
Code Information |
G150101 |
Recalling Firm/ Manufacturer |
TITAN SPINE, LLC 6140 W Executive Dr Suite A Mequon WI 53092-4499
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For Additional Information Contact | Andrew Shepherd 262-242-7801 |
Manufacturer Reason for Recall | The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drivers (5210-1004) Lot# G150101 from the field. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Titan Spine sent an "Urgent Medical Device Recall" letter via Fed Ex dated February 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
A replacement TCS Straight Hex lobular# 6 Drivers (5210-1004) will be shipped out to each Titan Spine Area Vice President and Sales Rep. within 4-6 weeks.
For further questions please call (262) 242-7801. |
Quantity in Commerce | 26 |
Distribution | US Distribution to the states of : AZ, CA, CT, FL, GA, ID, IL, KY, MD, MO, NV, NY, OH, OK, OR, TX, UT and WI. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = OVE
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