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U.S. Department of Health and Human Services

Class 2 Device Recall Endo TCS Driver Straight Hexalobe 6 P/N 52101004,

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  Class 2 Device Recall Endo TCS Driver Straight Hexalobe 6 P/N 52101004, see related information
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
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
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
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 = OVE and Original Applicant = TITAN SPINE, LLC
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