BEUDAMED
    22 results · 31ms · Sources: EU EUDAMED, US FDA

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    ZMR HIP SYSTEM FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWZ·April 3, 2015

    PROVEN KNEE COMPONENT

    FDA Adverse Event
    Malfunction ·STELKAST CO.·Product code JWH·June 21, 2000

    PROVEN KNEE COMPONENT

    FDA Adverse Event
    Malfunction ·STELKAST CO.·Product code JWH·June 21, 2000

    SRRS PRESSED FIT REVISION STEM

    FDA Adverse Event
    Malfunction ·STELKAST CO.·Product code LWJ·December 21, 2001

    PROVEN KNEE COMPONENT

    FDA Adverse Event
    Malfunction ·STELKAST CO·Product code HTG·January 25, 2001

    PROVEN KNEE INSTRUMENT

    FDA Adverse Event
    Other ·STELKAST CO.·Product code LXH·October 29, 1999

    EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

    FDA Enforcement
    Class II ·Terminated·Stelkast Co·January 21, 2015

    Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.

    FDA Enforcement
    Class II ·Terminated·Stelkast Co·April 17, 2013

    SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.

    FDA Enforcement
    Class II ·Terminated·Stelkast Co·September 11, 2013

    Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present.

    FDA Recall
    Terminated ·Stelkast Co·Product code LWJ·October 31, 2008

    StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number: SC2287-5-5, Size 5, Thickness 5 mm, StelKast, Murray, PA 15317

    FDA Recall
    Terminated ·Stelkast Co·Product code JWH·October 5, 2007

    Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.

    FDA Recall
    Terminated ·Stelkast Co·Product code OQG·January 24, 2013

    Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439

    FDA Recall
    Terminated ·Stelkast Co·Product code LWJ·October 7, 2008

    Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm. The Proven Knee System is a single use device intended for cemented reconstruction of the femoral and/or tibial portion of severely disabled and/or painful knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis with or without varus, valgus or flexion deformities, and revision surgery provided that there is radiographic evidence of sufficient sound bone to seat the prosthesis.

    FDA Recall
    Terminated ·Stelkast Co·Product code JWH·September 3, 2008

    Proven Porous CR Femur. Implantable orthopedic device

    FDA Recall
    Terminated ·Stelkast Co·Product code JWH·September 24, 2004

    StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm, StelKast, Murray, PA 15317

    FDA Recall
    Terminated ·Stelkast Co·Product code JWH·October 5, 2007

    SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.

    FDA Recall
    Terminated ·Stelkast Co·Product code JWH·June 24, 2013

    StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-2-5, Size 2 Thickness 5 mm, StelKast, Murray, PA 15317

    FDA Recall
    Terminated ·Stelkast Co·Product code JWH·October 5, 2007

    StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-4-5, Size 4, Thickness 5 mm, StelKast, Murray, PA 15317

    FDA Recall
    Terminated ·Stelkast Co·Product code JWH·October 5, 2007

    StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-3-5, Size 3, Thickness 5 mm, StelKast, Murray, PA 15317

    FDA Recall
    Terminated ·Stelkast Co·Product code JWH·October 5, 2007