Integra Recalls Salto Talaris Ankle Prosthesis Due to Labeling Error
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels 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 indicates the issue is a labeling error (incorrect symbol) with no reported illnesses or injuries, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left (Part No. LJU213T). The recall was initiated because the product labels, including the box, inner pouch, and Instructions for Use (IFU), 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 source text does not specify the exact dates of distribution or the specific hospitals or clinics that received the product.
This is a Class II recall, meaning there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences. The FDA has not reported any illnesses or injuries associated with this labeling error. Healthcare providers and patients should contact their medical device representative or the manufacturer for further instructions on how to handle the affected units.
The recalled product
- Product
- Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T
- 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)
- 180075 181348
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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