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 involves a labeling error regarding material composition. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries are rated as Moderate.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Talar Dome Total Ankle Prosthesis, Sloped, Size 3, Right (Product No. LJV183T). 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 on the implant.
The affected products 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 182859, 183347, and 183348.
Healthcare providers and patients should verify the product number and lot codes against this recall notice. If the product matches the description, it should be removed from use and returned to the manufacturer or distributor according to their instructions.
The recalled product
- Product
- Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T
- 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)
- 182859 183347 183348
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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