Integra Talar Dome Total Ankle Prosthesis Recalled for Incorrect Labeling
Integra LifeSciences Corp. is recalling Talar Dome Total Ankle Prostheses because the labels 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, which fits the criteria for moderate severity involving minor labeling errors.
Plain-English summary
Integra LifeSciences Corp. is recalling the Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Left, Product No. LJU823T. The recall involves 2,029 units of the implant.
The recall was initiated because the Salto Talaris and Integra XT Revision implant labeling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and the Instructions for Use (IFU). The affected units were distributed to distributors in AL, CA, CT, FL, GA, HI, IA, ID, KS, KY, MD, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, TX, VA, WA, and WI.
Healthcare providers and patients should stop using the affected implants and contact the manufacturer for further instructions.
The recalled product
- Product
- Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T
- 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)
- 180081
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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