FDAClass IIAugust 12, 2015

Titan Spine Endoskeleton Locking Bone Screw Assembly recall

Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers /…

Why was Titan Spine Endoskeleton Locking Bone Screw Assembly recalled?

Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: V03, V05, V06

Product
Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers /…
Recalling firm
TITAN SPINE, LLC
Quantity
137 units
Distribution
Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
Recall date
August 12, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls