Recall Z-2024-2021 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Vivorte, Inc.
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
| Date | Jul 7, 2021 (initiated Sep 9, 2018) |
| Status | Terminated |
| Reason | incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018 |
| Root cause | Labeling Change Control |
| Action | Vivorte issued Medical Device Removal letter via email on 9/7/2018. Letter states reason for recall, health risk and action to be taken: We recommend that you take the following short-term actions: Ship any Trabexus EB lot MA-170727-01 back to Vivort, Inc. using the included product replacement form. Lot MA-170727-01 will be relabeled to be sent back to you upon request. Contact Therese Montano at tmontano@vivorte.com with further questions |
| Quantity | 12 units |
| Distribution | US state of KY |
| FDA record | Open on fda.gov |