Integra Talar Dome Total Ankle Prosthesis Recalled for Labeling Error
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. The source text does not report any illnesses or injuries, and the hazard is limited to documentation accuracy rather than a direct physical defect or contamination.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Talar Dome Total Ankle Prosthesis, Flat Cut, Size 2, Right (Product No. LJU812T). The recall was initiated because the implant labels (on the box and inner pouch) and 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 associated with this recall are 180077, 182902, and 185086.
This recall is classified as Class II by the FDA. No illnesses or injuries have been reported in connection with this labeling error. Healthcare providers and patients should verify the product details against the recall notice and contact the manufacturer or their supplier for further instructions on how to proceed.
The recalled product
- Product
- Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
- 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)
- 180077 182902 185086
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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