FDA recall Z-0086-2022

Medtronic Sofamor Danek USA Inc · Class II · device

Product

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

Reason for recall

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

Distribution

Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV

Key facts

Status
Terminated
Initiation date
2021-09-02
Report date
2021-10-20
Termination date
2023-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

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