FDAClass IIApril 28, 2021

Endoskeleton TC Interbody System with Titan nanoLOCK recall

Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated…

Why was Endoskeleton TC Interbody System with Titan nanoLOCK recalled?

The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

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?

GTIN 00191375013006, Lot Number TM0126527

Product
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated…
Recalling firm
Medtronic Sofamor Danek USA, Inc
Quantity
11 devices
Distribution
US Nationwide distribution.
Recall date
April 28, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls