Integra Talar Dome Total 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 without reported injuries or illnesses, 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 2, Right (Product No. LJV182T). The recall was initiated because the implant labels on the box and inner pouch, as well as the Instructions for Use (IFU), were found to list an incorrect metallic coating material symbol.
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 involved are 182857, 182858, 183345, and 183346.
Healthcare providers and distributors should stop using the affected products and contact the recalling firm for further instructions. Patients who have already received the implant should consult their healthcare provider regarding the labeling discrepancy.
The recalled product
- Product
- Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
- 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)
- 182857 182858 183345 183346
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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