Integra Recalls Salto Talaris Ankle Prosthesis Due to Labeling Error
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays 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 hazard is a labeling error regarding material symbols with no reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Integra LifeSciences Corp. is recalling the Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T. The recall involves 2,029 units that were distributed to distributors in 27 states, including Alabama, California, and Texas.
The recall was initiated because the product labeling on the metallic implant labels (box and inner pouch) and the Instructions for Use (IFU) listed an incorrect metallic coating material symbol. This labeling error affects the Salto Talaris and Integra XT Revision implants.
Healthcare providers and patients should contact their medical device representative or the manufacturer to verify if they have received the affected product. No specific instructions for patient action are provided in the source text beyond the identification of the labeling discrepancy.
The recalled product
- Product
- Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T
- 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)
- 180859
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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