Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is on
FDA device recall Z-1324-2015 · posted 2015-03-26 · Terminated
Recall details
- Recalling firm
- TITAN SPINE, LLC
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OVE
- Quantity affected
- 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.
- Date initiated
- 2015-02-20
- Date posted
- 2015-03-26
- Date terminated
- 2015-04-17
- Location
- Mequon, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Endoskeleton TCS System (K142940) | Titan Spine, LLC | 2015-01-28 |