Integra Recalls Salto Talaris Ankle Prosthesis Due to Labeling Error
Integra LifeSciences is recalling Salto Talaris and Integra XT Revision ankle prostheses because the labels incorrectly identify the metallic coating material.
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 regarding the metallic coating symbol. There are no reported illnesses or injuries, and the hazard is theoretical, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Integra LifeSciences Corp. is recalling the Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T. The recall also covers the Salto Talaris and Integra XT Revision implant lines. The issue is that the metallic implant labels, including the box, inner pouch, and Instructions for Use (IFU), list an incorrect metallic coating material symbol.
The recall involves 2,029 units. These 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 affected lot codes are 181146 and 181718.
This is a Class II recall, meaning the product may cause temporary or medically reversible health consequences. The FDA has not reported any illnesses or injuries associated with this labeling error. Healthcare providers and patients should check their inventory and patient records for these specific part numbers and lot codes. If the product is in use, providers should contact Integra LifeSciences for guidance on next steps.
The recalled product
- Product
- Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T
- 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)
- 181146 181718
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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