Integra Talar Dome Total Ankle Prosthesis Recalled for Incorrect Labeling
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses 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 without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,029 units of the Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right (Product No. LJV182T). The recall was initiated because the implant labels on the box and inner pouch, as well as the Instructions for Use (IFU), were found to 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 involved are 182857, 182858, 183345, and 183346.
Healthcare providers and distributors should stop using the affected products and contact the recalling firm for further instructions. Patients who have already received the implant should consult their healthcare provider regarding the labeling discrepancy.
The recalled product
- Product
- Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
- 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)
- 182857 182858 183345 183346
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.
See all 26 products in this recall →Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateDT MedTech Recalls Ankle Implant Due to Incorrect Package Labeling
FDA (Devices) · 2018-11-14
- ModerateIntegra LifeSciences Recalls Cadence Tibial Tray Implant Due to Labeling Error
FDA (Devices) · 2016-07-06
- HighINBONE Total Ankle System recalled for package-labeling mismatch
FDA (Devices) · 2021-12-08
- HighHintermann left talar implant packaging contained a right-side device
FDA (Devices) · 2026-06-17
- LowINBONE Total Ankle System Recalled Due to Package Labeling Mismatch
FDA (Devices) · 2021-12-08
- ModerateInnovasis Recalls Excella II Titanium Spine Rods Due to Labeling Error
FDA (Devices) · 2016-01-27