Titan Spine recalls
Titan Spine appears in 3 official U.S. recall notices indexed by RecallRadar, most recently on 2015-08-12.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 3 |
|---|---|
| Published | 2012-12-26 to 2015-08-12 |
| By agency | FDA Device (3) |
| By classification | Class II (3) |
| By status | terminated (3) |
| Distribution named in notices | AZ, CA, CT, FL, GA, ID, IL, IN, KY, MA, MD, MO, NV, NY, OH, OK, OR, TX, US, UT, WI |
Recalls
- Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant
FDA Device · Class II · 2015-08-12 · Titan Spine
Reason: Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. - Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instrument…
FDA Device · Class II · 2015-04-01 · Titan Spine
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… - Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant…
FDA Device · Class II · 2012-12-26 · Titan Spine
Reason: Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.