FDA Enforcement
Class II
Terminated
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Recall: Z-0085-2022
·
Reported October 20, 2021
Enforcement
- Recall Number
- Z-0085-2022
- 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" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Reason
Engraving on implants may not match what is listed on the pouch labels.
Code Info
Product Number 2312-0212-N, Lot A200323 GTIN 00191375014171
Distribution
Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Quantity
10 units