Integra Salto Talaris Ankle Prosthesis Recalled for Incorrect Labeling
Integra LifeSciences is recalling Salto Talaris and Integra XT Revision ankle prostheses 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 and involves a labeling error regarding material symbols. The source text does not report any illnesses or injuries, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Integra LifeSciences Corp. is recalling the Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T, as well as Salto Talaris and Integra XT Revision implants. The recall was initiated because the metallic implant labels, including the box, inner pouch, and 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 source text does not specify the total number of units recalled, specific lot numbers, or the dates of distribution.
Healthcare providers and patients should contact their healthcare provider or the recalling firm for further information regarding the replacement or return of these devices. The source text does not report any illnesses or injuries associated with this labeling error.
The recalled product
- Product
- Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T
- 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)
- 181147 181719 181720 183669
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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