Integra LifeSciences Recalls Tibial Total Ankle Prosthesis Trays Due to Labeling Error
Integra LifeSciences is recalling 2,029 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 1 (Product No. LJU221T). The recall was initiated because the product labels (on the box and inner pouch) and the Instructions for Use (IFU) list an incorrect metallic coating material symbol.
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 specific lot codes associated with this recall are 180750, 180860, 180861, 180892, and 181432.
Healthcare providers and distributors should stop using the affected trays and contact Integra LifeSciences Corp. for further instructions. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T
- 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)
- 180750 180860 180861 180892 181432
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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