Exactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Mismatch
Exactech, Inc. is recalling nine Vantage Total Ankle Tibial Inserts because the inner labeling and packaged device may not match the outer box label.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling mismatch which is a minor labeling error without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Exactech, Inc. is recalling nine units of the Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. The recall was initiated because the inner labeling and the packaged device may not match the outer label on the box. The affected units are identified by Catalog Number 350-21-43 and Serial Range 4537323 - 4537331, with an expiration date of August 2024.
The devices were distributed in North Carolina. The Vantage Total Ankle Tibial Insert is intended for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis, as well as for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The device is indicated for cemented use only.
Consumers and healthcare providers should check their inventory for the specific catalog and serial numbers listed above. If the device is found, it should be removed from use and returned to Exactech, Inc. according to the company's instructions.
The recalled product
- Product
- Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where…
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 9
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 (3)
- Catalog Number 350-21-43
- Serial Range 4537323 - 4537331
- Expiration August 2024
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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