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Zimmer Biomet, Inc. - Oxford Fixed Lateral Partial Knee System - Class 2 Recall
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The pouch and carton labels also contain sterilization indicator dots. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartment...
Source: Medical Device Recalls - January 7, 2017 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Titanium Single Vector Distractor Body and Proximal Foot Plate - Class 2 Recall
TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Titanium Single Vector Distractor Body and Proximal Foot Plate - Class 2 Recall
TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Titanium Single Vector Distractor Body and Proximal Foot Plate - Class 2 Recall
TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Titanium Single Vector Distractor Body and Proximal Foot Plate - Class 2 Recall
TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Titanium Single Vector Distractor Body and Proximal Foot Plate - Class 2 Recall
TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Titanium Single Vector Distractor Body and Proximal Foot Plate - Class 2 Recall
TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts

Zimmer Gmbh - Avenir Mller Stem - Class 2 Recall
Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute traumatic fracture of the femoral head or neck " Avascular necrosis of the femoral head. " Avenir Moller Stems are for cementless use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 27, 2016 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - Femoral Stems - Class 2 Recall
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 6, 2016 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - Femoral Stems - Class 2 Recall
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation. (Source:...
Source: Medical Device Recalls - July 6, 2016 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - LEGION(TM) HK FEMORAL ASSEMBLY - Class 2 Recall
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEG...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - LEGION(TM) HK FEMORAL ASSEMBLY - Class 2 Recall
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGIO...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - LEGION(TM) HK FEMORAL ASSEMBLY - Class 2 Recall
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGI...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - LEGION(TM) HK FEMORAL ASSEMBLY - Class 2 Recall
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEG...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - LEGION(TM) HK FEMORAL ASSEMBLY - Class 2 Recall
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts