Integra Talar Dome Total Ankle Prosthesis Recalled for Incorrect Labeling
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.
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 the hazard is a labeling error regarding material identification without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Right (Product No. LJU811T). The recall involves specific lot codes 180076, 180082, and 185085.
The recall was initiated because the implant labels, including the box, inner pouch, and Instructions for Use (IFU), list an incorrect metallic coating material symbol. This labeling error affects the Salto Talaris and Integra XT Revision implant lines.
The affected devices 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. Healthcare providers and patients should verify the product number and lot codes against this recall notice and contact the manufacturer for further instructions.
The recalled product
- Product
- Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T
- 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)
- 180076 180082 185085
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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