Recall Z-0086-2022 · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Medtronic Sofamor Danek USA Inc
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
| Date | Sep 2, 2021 |
| Status | Terminated |
| Reason | Engraving on implants may not match what is listed on the pouch labels. |
| Root cause | Packaging change control |
| Action | A customer letter was sent via FedEx to impacted US consignees and delivered on or about September 3, 2021. Customers are asked to locate and remove the impacted product from normal storage locations. Customers are advised to not use product. A Customer Confirmation Form should be completed and returned to rs.sdmriskmgt@medtronic.com. Customers may also coordinate return and replacement of impacted product with the Medtronic Sales Representative. This recall notice should be forwarded to those within the customer organization or to any organization where potentially impacted devices have |
| Quantity | 9 units |
| Distribution | Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151596 | Endoskeleton TCS Interbody Fusion Device Titan Spine, LLC, Oct 9, 2015 |
| K153122 | Endoskeleton(r) TCS System Titan Spine, LLC, Dec 14, 2015 |
| K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Titan Spine, LLC, Feb 13, 2018 |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion D Titan Spine, Inc., Feb 11, 2019 |
| K191565 | Endoskeleton TCS Interbody Fusion Device Titan Spine, Inc., Aug 6, 2019 |
| K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Titan Spine, Inc., Aug 16, 2019 |