Exactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Error
Exactech is recalling 11 Vantage Total Ankle Tibial Inserts because the labels incorrectly identify the implant size as 3 instead of 4.
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 minor labeling error regarding size identification, which aligns with the rubric criteria for moderate severity.
Plain-English summary
Exactech, Inc. is recalling 11 units of the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm. The recall was initiated because a labeling error was identified on the product.
The upper right corner of the label incorrectly identifies the implant size as 3, whereas the actual implant size is 4. The affected units are identified by Catalog Number 350-22-44, Lot numbers 05144883 and 05144884, and specific serial numbers listed in the agency record.
The products were distributed domestically to Colorado, Florida, Oklahoma, and Pennsylvania, as well as internationally to Chile. Consumers and healthcare providers should verify the specific lot and serial numbers of their implants against the recall notice to determine if they are affected.
The recalled product
- Product
- The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 11
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 (10)
- 6417989
- 6417996
- 6417997
- 6417998
- 6418002
- 6418003
- 6488668
- 6488673
- 6488674
- 6488675.
Distribution
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