Integra Tibial Total Ankle Prosthesis Tray Recalled for Labeling Errors
Integra LifeSciences is recalling Tibial Total Ankle Prosthesis Trays due to incorrect metallic coating symbols on labels and instructions.
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 due to a labeling error (incorrect metallic coating symbol) which is a minor labeling issue that could temporarily cause or contribute to reversible adverse health consequences, fitting the Moderate severity criteria.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T. The recall involves specific lot codes: 180751, 180893, 181149, 181150, 181151, 185084, and 180894.
The recall was initiated because the Salto Talaris and Integra XT Revision implant labeling listed an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and the Instructions for Use (IFU). This is a Class II recall, indicating a situation that could temporarily cause or contribute to reversible adverse health consequences.
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. Healthcare providers and patients should contact the manufacturer for further instructions regarding the use or replacement of these devices.
The recalled product
- Product
- Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
- 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)
- 180751 180893 181149 181150 181151 185084 180894
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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