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Medtronic Sofamor Danek USA, Inc recalls Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208
Recalled April 28, 2021 · FDA recall Z-1439-2021 · Medtronic Sofamor Danek USA
Hazard
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. · FDA Class II
Units
11 devices
Sold at
US Nationwide distribution.
Description
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.
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.
Manufacturer(s)
Medtronic Sofamor Danek USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →