Z-0085-2022 Class II Terminated
FDA device recall Z-0085-2022 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: 10 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
- 10 units
Product Description
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 Pattern
Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Code Information
Product Number 2312-0212-N, Lot A200323 GTIN 00191375014171