Titan Spine Recalls Endoskeleton Locking Bone Screw Assemblies
Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assemblies because the locking collars are not locking.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical failure in a spinal implant where the locking mechanism is not functioning, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Titan Spine, LLC is recalling specific units of the Endoskeleton TCS Integrated Locking Bone Screw Assembly. This product is a spinal implant that is part of the Endoskeleton TCS Interbody Fusion Device. The recall involves 137 units with lot numbers V03, V05, and V06.
The recall was initiated because the locking bone screw collars are not locking. The affected products were distributed in the states of California, Texas, Oklahoma, Massachusetts, New York, Indiana, Oregon, and Georgia.
Consumers and healthcare providers should contact Titan Spine, LLC for further instructions regarding the return or replacement of these specific spinal implant components.
The recalled product
- Product
- Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm…
- Manufacturer
- TITAN SPINE, LLC
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 137
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot numbers: V03
- V05
- V06
Distribution
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