Z-1324-2015 Class II Terminated
FDA device recall Z-1324-2015 was initiated by TITAN SPINE, LLC on February 20, 2015 and is designated Class II. 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 … The recall status is terminated (terminated April 17, 2015). Affected quantity: 26.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2015
- Initiation Date
- February 20, 2015
- Termination Date
- April 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26
Product Description
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).
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.
Distribution Pattern
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.
Code Information
G150101