FDA-Device2021-10-20Class II

Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm

Medtronic Sofamor Danek USA Inc
Hazard

Engraving on implants may not match what is listed on the pouch labels.

Sold states
Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Affected count
9 units
Manufactured in
1800 Pyramid Pl, N/A, Memphis, TN, United States
Products
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0086-2022

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