FDA (Devices) recall action 82377
The FDA (Devices) publishes a recall like this one as 26 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 26 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Integra LifeSciences is recalling Salto Talaris and Integra XT Revision ankle prostheses because the labels incorrectly identify the metallic coating material.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling 2,029 Tibial Total Ankle Prosthesis Trays because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly list the metallic coating material symbol.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels incorrectly identify the metallic coating material.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays due to incorrect metallic coating material symbols on labels and instructions.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Salto Talaris and Integra XT Revision ankle prostheses because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Tibial Total Ankle Prosthesis Trays due to incorrect metallic coating symbols on labels and instructions.
Integra LifeSciences is recalling 2,029 Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences Corp. is recalling Talar Dome Total Ankle Prostheses because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences Corp. is recalling Tibial Total Ankle Prosthesis Trays because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences Corp. is recalling Tibial Total Ankle Prosthesis Trays because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.