FDA-Device2021-04-28Class II
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.
Medtronic Sofamor Danek USA, Inc
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.
Sold states
US Nationwide distribution.
Affected count
11 devices
Manufactured in
4340 Swinnea Rd, N/A, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1439-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief