Integra Tibial Total Ankle Prosthesis Tray Recalled for Labeling Error
Integra LifeSciences Corp. is recalling Tibial Total Ankle Prosthesis Trays because the labels and instructions for use 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. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Tibial Total Ankle Prosthesis Tray, Size 3 (Product No. LJU223T). The recall involves specific lots identified by codes 180894 and 181152.
The recall was initiated because the product labels on the box and inner pouch, as well as the Instructions for Use (IFU), list an incorrect metallic coating material symbol. This labeling error affects the Salto Talaris and Integra XT Revision implant lines.
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. Healthcare providers and patients should contact their medical device representative or the manufacturer for further information regarding this labeling discrepancy.
The recalled product
- Product
- Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T
- 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)
- 180894 181152
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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