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. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Talar Dome Total Ankle Prosthesis, Sloped, Size 1, Left (Product No. LJV191T). The recall was initiated because the product 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 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 182860, 182861, 183350, and 183351.
Healthcare providers and distributors should stop using the affected units and contact Integra LifeSciences for further instructions. This recall addresses a labeling discrepancy regarding the metallic coating material symbol and does not indicate a defect in the physical implant itself.
The recalled product
- Product
- Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
- 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)
- 182860 182861 183350 183351
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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