Siemens Healthcare Diagnostics, Inc. - Dimension Vista beta2Microglobulin Flex Reagent Cartridge (B2MIC) - Class 2 Recall
Dimension Vista¿ ¿2-Microglobulin Flex¿ Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of ¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista¿ System. Measurements of ¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2015 Category: Medical Equipment Source Type: alerts
Omnilife Science Inc. - APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells - Class 2 Recall
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional defor...
Source: Medical Device Recalls - August 22, 2015 Category: Medical Equipment Source Type: alerts
Aesculap Implant Systems - Columbus Tibia Plateau (component of the Columbus REVISION Knee System) - Class 2 Recall
Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
Medacta Usa Inc - EvolisFemoral Sizer Posterior Reference - Class 2 Recall
Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The femoral sizer is an alternate instrument that can be used in addition to the standard MIS femoral sizer. The Femoral Sizer Posterior Reference intended to be placed on the distal femoral cut and determine the trail size and set the external rotation in preparation for the cut blocks. The femoral sizer posterior reference is intended to be placed on the distal femoral cut and determine the trial size and set the external ro...
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
Zimmer, Inc. - Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology - Class 1 Recall
M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck ...
Source: Medical Device Recalls - June 9, 2015 Category: Medical Equipment Source Type: alerts
Stelkast Co - EXp Tibial Insert - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2015 Category: Medical Equipment Source Type: alerts
Zimmer, Inc. - Persona Stemmed 5 Degree Cemented Tibia - Class 2 Recall
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. T...
Source: Medical Device Recalls - November 9, 2014 Category: Medical Equipment Source Type: alerts
RHEUMATOID ARTHRITIS NOSODE (Atp (Adenosine Triphosphate Disodium), Malic Acid, Natrum Oxalaceticum, Riboflavinum, Apiolum, Cinnamic Acid, Dhea (Dehydroepiandrosterone), Streptococcus Viridans) Liquid [Deseret Biologicals, Inc.]
Updated Date: Jul 16, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - July 16, 2014 Category: Drugs & Pharmacology Source Type: alerts
Zimmer, Inc. - NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat - Class 2 Recall
***LOT***NexGen¿ Complete Knee Solution***MIS Total Knee Procedure***Stemmed***Tibial Component***Precoat***Fixed Bearing***Size*** NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; Collagen disorders, and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, va...
Source: Medical Device Recalls - June 28, 2014 Category: Medical Equipment Source Type: alerts
