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Arthrosurface, Inc. - The HemiCAP Contoured Articular Prosthetic; 25&38;30mm 10.5x28mm - Class 2 Recall
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035 The HemiCAP¿ Contoured Articular Prosthetic incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface. Indications for Use: For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient b...
Source: Medical Device Recalls - February 13, 2015 Category: Medical Equipment Source Type: alerts

Arthrosurface, Inc. - The HemiCAP Contoured Articular Prosthetic; 25&38;30mm 10.5x28mm - Class 2 Recall
Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028 The HemiCAP¿ Contoured Articular Prosthetic incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface. Indications for Use: For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bon...
Source: Medical Device Recalls - February 13, 2015 Category: Medical Equipment Source Type: alerts

Arthrosurface, Inc. - The HemiCAP Contoured Articular Prosthetic; 25&38;30mm 10.5x28mm - Class 2 Recall
Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032 The HemiCAP¿ Contoured Articular Prosthetic incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface. Indications for Use: For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone sto...
Source: Medical Device Recalls - February 13, 2015 Category: Medical Equipment Source Type: alerts

Arthrosurface, Inc. - The HemiCAP Contoured Articular Prosthetic; 25&38;30mm 10.5x28mm - Class 2 Recall
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032 The HemiCAP¿ Contoured Articular Prosthetic incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface. Indications for Use: For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bon...
Source: Medical Device Recalls - February 13, 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

Integra LifeSciences Corp. - Ascension Orthopedics PyroSphere CMC & PyroSphere TMT - Class 2 Recall
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 17, 2014 Category: Medical Equipment Source Type: alerts

Skeletal Dynamics - Align Radial Stem - Class 2 Recall
Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 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

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