Exactech Vantage Total Ankle Tibial Insert Recalled for Labeling Mismatch
Exactech is recalling nine Vantage Total Ankle Tibial Inserts due to possible mismatches between inner and outer packaging labels.
What this means for you
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 involves a labeling error where the device may not match the packaging. This fits the rubric for moderate severity, as it is a labeling issue without reported injuries or deaths.
Plain-English summary
Exactech, Inc. is recalling nine units of the Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. The recall is due to a possible discrepancy where the inner labeling and the packaged device do not match the outer label on the box.
The affected devices are identified by Catalog Number 350-21-13 and Serial Range 4536756 - 4536764, with an expiration date of August 2024. These units were distributed in North Carolina. The devices are intended for patients with ankle joint damage caused by severe rheumatoid, post-traumatic, or degenerative arthritis, and are indicated for cemented use only.
Healthcare providers and patients should verify that the device matches the outer label before use. If a mismatch is found, the device should not be used and the facility should contact Exactech for further instructions.
The recalled product
- Product
- Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 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 su
- 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 350-21-13
- Serial Range 4536756 - 4536764
- 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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