FDA Enforcement
Class II
Terminated
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Recall: Z-0086-2022
·
Reported October 20, 2021
Enforcement
- Recall Number
- Z-0086-2022
- Event ID
- 88684
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Sofamor Danek USA Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 20, 2021
- Initiation Date
- September 2, 2021
- Classification Date
- October 12, 2021
- Termination Date
- October 5, 2023
- Address
- 1800 Pyramid Pl, N/A, Memphis, TN, 38132-1703, United States
Description
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Reason
Engraving on implants may not match what is listed on the pouch labels.
Code Info
Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490
Distribution
Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Quantity
9 units