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.
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, but the source text explicitly states the issue is a labeling error with no reported illnesses or injuries, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Integra LifeSciences Corp. is recalling the Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T. The recall involves 2,029 units that 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 recall was initiated because the implant labeling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and the Instructions for Use (IFU). The source text does not report any illnesses, injuries, or deaths associated with this labeling error.
Consumers and healthcare providers should contact their healthcare provider or the recalling firm for further instructions regarding the use or return of these specific devices.
The recalled product
- Product
- Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T
- 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)
- 180073 181259 182899
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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