← RecallGuard
HomeRecalls

Integra LifeSciences Corp. Recall: Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Ri

Integra LifeSciences Corp. Recall: Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Ri is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Integra LifeSciences Corp.; Product: Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T; Reason for recall: The Salto

Recalling firmIntegra LifeSciences Corp.
ProductTalar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
Reason for recallThe 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
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionDistributors 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.
Recall initiated20190308
Recall numberZ-1167-2019
Categorydevice
StateNJ
CountryUnited States

🔍 Search all recalls →