Integra Talar Dome Total Ankle Prosthesis Recalled for Labeling Error
Integra LifeSciences is recalling 2,029 Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text explicitly states the issue is a labeling error (incorrect symbol) and does not report any illnesses or injuries. Per the rubric, minor labeling errors or voluntary precautionary recalls without reported harm fall under Moderate (Score 2).
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left (Product No. LJU821T). The recall was initiated because the implant labels (on the box and inner pouch) and the Instructions for Use (IFU) 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 source text notes that the labeling error was found on the Salto Talaris and Integra XT Revision implant labels.
This is a Class II recall, which means the product may cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries associated with this labeling error. Healthcare providers and distributors should stop using the affected units and contact the manufacturer for instructions on how to return or dispose of them.
The recalled product
- Product
- Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
- 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)
- 180079 181349
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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