PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: October 20, 2021 Initiated: September 2, 2021 #Z-0086-2022

Product Description

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.

Details

Units Affected
9 units
Distribution
Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 9 units.
Why was this product recalled?
Engraving on implants may not match what is listed on the pouch labels.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0086-2022.