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.
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 error regarding material symbols rather than a direct physical defect or contamination, fitting the criteria for moderate severity.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Talar Dome Total Ankle Prosthesis, Sloped, Size 0, Right (Product No. LJV180T). 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. The specific lot codes associated with this recall are 182853, 182854, and 183344.
Healthcare providers and distributors should stop using the affected implants and contact the manufacturer for instructions on how to return or dispose of the products. Patients who have already received these implants should contact their healthcare provider to discuss the labeling discrepancy and any necessary follow-up care.
The recalled product
- Product
- Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
- 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)
- 182853 182854 183344
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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