FDAClass IIDecember 26, 2012

Titan Spine Endoskeleton TA Implant products. 2107-0118 recall: Labeling Error

Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR…

Why was Titan Spine Endoskeleton TA Implant products. 2107-0118 recalled?

Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.

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?

Model # / Lot # 2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813. 2107-0220: A110828, A120262, A120305, A120801, A120901.

Product
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR…
Recalling firm
TITAN SPINE, LLC
Quantity
92 pcs.
Distribution
Nationwide Distribution including NV
Recall date
December 26, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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