Recall Z-1324-2015 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
TITAN SPINE, LLC
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).
| Date | Mar 26, 2015 (initiated Feb 20, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142940 | Endoskeleton TCS System Titan Spine, LLC, Jan 28, 2015 |