FDA recall Z-0085-2022

Medtronic Sofamor Danek USA Inc · Class II · device

Product

Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm

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-0085-2022