medical Class II Updated 2021-04-28

Medtronic Sofamor Danek USA, Inc recalls Endoskeleton TC Interbody System with Titan nanoLOCK Surface

Recalled Product

Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN 00191375013006, Lot Number TM0126527
View official government recall

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