Integra Tibial Total Ankle Prosthesis Tray Recalled for Labeling Error
Integra LifeSciences Corp. is recalling 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 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 0, Product No. LJU220T. The recall was initiated because the implant labeling for the Salto Talaris and Integra XT Revision systems 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 specific lot code associated with this recall is 181148.
Healthcare providers and patients should verify the product number and lot code of their Tibial Total Ankle Prosthesis Trays against this recall notice. If the product matches the recalled description, users should contact Integra LifeSciences Corp. for further instructions on how to proceed.
The recalled product
- Product
- Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T
- 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)
- 181148
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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