Medtronic Sofamor Danek USA Inc Recall 88684
Description: Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Medtronic Sofamor Danek USA Inc Recall 88684 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0086-2022 |
| Event ID | 88684 |
| Event Description | Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm |
| Product Type | Devices |
| Distribution | Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV |
| Quantity | 9 units |
| Recall Reason | Engraving on implants may not match what is listed on the pouch labels. |
| Device Classification | 20211020 |
| Device Code Info | Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490 |
| Center Classification Date | 20211012 |
| Recall Initiation Date | 20210902 |
| Recalling Firm | Medtronic Sofamor Danek USA Inc |
| Initial Notification | Letter |
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