Integra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
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 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 the Talar Dome Total Ankle Prosthesis, Sloped, Size 3, Left (Product No. LJV193T). The recall involves 2,029 units 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.
The recall was initiated because the implant labeling, including the box, inner pouch, and Instructions for Use (IFU), was found to list an incorrect metallic coating material symbol. The source text notes that this labeling error was found on the Salto Talaris and Integra XT Revision implant labels.
Consumers and healthcare providers should contact the recalling firm for further instructions on how to handle the affected devices.
The recalled product
- Product
- Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
- 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)
- 182863 182864 183354
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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