FDA recall Z-1440-2021

Medtronic Sofamor Danek USA, Inc · Class II · device

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.

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2021-03-17
Report date
2021-04-28
Termination date
2023-05-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1440-2021