13 results
·
32ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
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
Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedure; and alternative to tibial osteotomy in patients with unicompartmental arthritis.
FDA Recall
Terminated
·Stelkast Co·Product code HSX·May 5, 2009
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 Recall
Terminated
·Stelkast Co·Product code JWH·December 1, 2014