Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
FDA device recall Z-2024-2021 · posted 2021-07-07 · Terminated
Recall details
- Recalling firm
- Vivorte, Inc.
- Reason for recall
- incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018
- Action taken
- 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
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- MBP
- Quantity affected
- 12 units
- Distribution
- US state of KY
- Date initiated
- 2018-09-09
- Date posted
- 2021-07-07
- Date terminated
- 2021-11-17
- Location
- Louisville, KY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Vivorte Trabexus EB (K143547) | Vivorte, Inc. | 2015-01-14 |
| VIVORTE BVF (K130703) | Vivorte, Inc. | 2013-09-12 |