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Other Medical Devices

Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS

Gyrus ACMI

Class I - Dangerous

Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable

Ethicon

Class I - Dangerous

VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

Mar 12, 2019 Other Medical Devices Nationwide View Details →

Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS

Gyrus ACMI

Class I - Dangerous

Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

BIOPHEN UFH Control C2, REF 223901

Aniara Diagnostica

Class I - Dangerous

The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

Mar 19, 2019 Other Medical Devices View Details →

Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS

Gyrus ACMI

Class I - Dangerous

Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

Mar 8, 2019 Other Medical Devices Nationwide View Details →

VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 VIO) VICRYL PLUS SUTURE 18"(45CM) 1 VIO VICRYL PLUS SUTURE 18"(45CM) 4-0 VIO VICRYL PLUS SUTURE 27"(70CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 2-0 UND VICRYL PLUS SUTURE 18"(45CM) 1 UND VICRYL PLUS SUTURE 27"(70CM) 0 UND VICRYL PLUS SUTURE 27"(70CM) 2-0 UND - Product Usage: Coated VICRYL Suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues

Ethicon

Class I - Dangerous

VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

Mar 12, 2019 Other Medical Devices Nationwide View Details →

Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T

Integra LifeSciences

Class I - Dangerous

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

Mar 8, 2019 Other Medical Devices Nationwide View Details →

Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC

Gyrus ACMI

Class I - Dangerous

Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

Mar 8, 2019 Other Medical Devices Nationwide View Details →

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