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, Large, 8 mm, Product Number 5146-1608-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
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