FDA-Device2019-04-24Class II
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
Integra LifeSciences Corp.
Hazard
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
Sold states
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.
Affected count
2029
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1167-2019Don't want to check this manually?
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