Vivorte Bone Void Filler Recalled for Incorrect Expiration Date
Vivorte, Inc. is recalling Trabexus EB bone filler due to an incorrect expiration date on product labels. The label shows expiration of 02-15-2019, but the actual expiration is 12-18-2018.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves an incorrect expiration date on a medical implant. While no illnesses or injuries have been reported, an expired bone filler poses a risk of harm to patients, qualifying this as a high-severity risk-of-harm product.
Plain-English summary
Vivorte, Inc. is recalling 12 units of Trabexus EB 10 cc Bone Void Filler (Model 130703-10) distributed in Kentucky due to an incorrect expiration date on product labels.
The product label lists an expiration date of 02-15-2019, but the correct expiration date is 12-18-2018. Affected units bear lot number MA-170727-01 (serial numbers 093 through 105).
Patients or healthcare providers with affected units should contact Vivorte, Inc. immediately for instructions on product management.
The recalled product
- Product
- Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
- Manufacturer
- Vivorte, Inc.
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 000XXX=>019046=}017239&
- 100000000MA17072701 where XXX ranges from 093 through 105.
Distribution
Distributed in 1 state:
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