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.
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, which fits the rubric criterion for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right (Product No. LJU813T). The recall is due to a labeling error where the metallic implant labels (on the box and inner pouch) and the Instructions for Use (IFU) list an incorrect metallic coating material symbol.
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 180078, 182903, 183670, and 190799.
Healthcare providers and patients should contact their healthcare provider or the recalling firm for further instructions regarding the use of these devices. This recall is classified as Class II by the FDA, indicating that misuse may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
- 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)
- 180078 182903 183670 190799
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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