Integra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.
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 regarding material symbols without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Talar Dome Total Ankle Prosthesis, Sloped, Size 0, Left (Product No. LJV190T). The recall was initiated because the product labels, including the box, inner pouch, and Instructions for Use (IFU), list an incorrect symbol for the metallic coating material.
The affected units were distributed to distributors in Alabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, and Wisconsin.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and patients should verify the product code and consult the manufacturer for further instructions regarding the use of these specific implants.
The recalled product
- Product
- Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 2,029
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 (1)
- 183349
Distribution
Part of a larger recall action
This product is one of 26 recalled by Integra LifeSciences Corp. 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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