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 and involves a labeling error (incorrect metallic coating symbol) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T. The recall was initiated because the product labeling was found to list an incorrect metallic coating material symbol on the metallic implant labels, including the box, inner pouch, and Instructions for Use (IFU).
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 does not specify the exact dates of distribution or the specific medical facilities that received the units.
Consumers and healthcare providers should stop using the affected products and contact the manufacturer for further instructions. The recall is classified as Class II by the FDA, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T
- 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)
- 181155 182900
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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