Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface… — Class II medical device recall Z-0086-2022
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2021-10-20, distributed in CA, MN, MO, NC, NV, NY, OH, OK…. Engraving on implants may not match what is listed on the pouch labels.
| Recall number | Z-0086-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2021-09-02 |
| Classified | 2021-10-12 |
| Reported by FDA | 2021-10-20 |
| Terminated | 2023-10-05 |
| Distributed | CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV |
| Quantity | 9 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00191375018490 |
| Lot numbers | A200510 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0086-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.