Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spi
FDA device recall Z-2327-2015 · posted 2015-08-03 · Terminated
Recall details
- Recalling firm
- TITAN SPINE, LLC
- Reason for recall
- Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
- Action taken
- Physicians and Distributors were sent on 7/20/2015 separate Titan "Urgent Medical Device Recall" letters dated July 20, 2015. The letters described the problem and the product involved in the recall. Advised consignees to complete and return the enclosed response form. For questions they contact Jane Rodd Senior AQ/RA Manager at 262-242-7801. Distributors were advised to examine their inventory and quarantine the product. If they have further distributed the product they should identify their customers and advise Titan Spine of their contact information.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OVE
- Quantity affected
- 137 units
- Distribution
- Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
- Date initiated
- 2015-07-20
- Date posted
- 2015-08-03
- Date terminated
- 2015-10-20
- Location
- Mequon, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Endoskeleton TCS System (K142940) | Titan Spine, LLC | 2015-01-28 |