Z-0086-2022 Class II Terminated
FDA device recall Z-0086-2022 was initiated by Medtronic Sofamor Danek USA Inc on September 2, 2021 and is designated Class II. Reason for recall: Engraving on implants may not match what is listed on the pouch labels. The recall status is terminated (terminated October 5, 2023). Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 20, 2021
- Initiation Date
- September 2, 2021
- Termination Date
- October 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
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.
Distribution Pattern
Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Code Information
Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490