Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1170-2019.
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1170-2019.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Integra Lifesciences Corp. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1170-2019.
Integra LifeSciences Corp.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Integra Lifesciences Corp. Recall FAQ
Integra Lifesciences Corp. is the subject of a medical implants safety report: Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T. The notice was published on March 8, 2019 by the U.S. Food and Drug Administration (FDA). Approximately 2,029 units are potentially affected.