BIONIT2 bipolar heads, references 1413-61-3, 1414-61- 3, 1415-61-3, 1416-61-3, 1417-61-3, 1418-61-3 and 1419-61-3, || specific lots.
Descripción del producto
For the partial or total artificial replacement of the joints of the body such as: hip, knee, shoulder and for the treatment of complex cases, osteoarthritis, joint instability, allowing to restore mobility, correct deformities, joint reconstruction, specific clinical indications according to the articulation and model or reference. Prosthesis for articular replacementMATHYS of shoulder primary osteoarthritis, secondary osteoarthritis, rheumatoid arthritis, post-traumatic osteoarthritis, arthropathy with rotator cuff tear (hamada grade III or IV) in young patients, joint metabolic deficiency (eg, chondrocalcinosis, hemosiderosis, urate arthropathies) , sequelae of fractures (healing of humeral head fractures, healing sinussion / pseudoarthrosis, necrosis of the head, blocked dislocations), avascular necrosis of the head (if there are sufficient bones), poly-fragmentary fractures and comminution of the humerus head with danger of disorders in fragment vascularization, proximal humerus fractures not treatable by osteosynthesis, secondary dislocation of the fragments subsequent to osteosynthesis in the proximal humerus, rotator cuff arthropathy (RDA), revision of total prosthesis or failed semiprosthesis in patients with pathological rotator cuff, in Certain tumor modifications of the proximal humerus. MATHYS joint replacement prosthesis of the hip: joint degenerative disease, such as primary or secondary coxarthritis, advanced loss of substance and functional loss of the hip joint caused by degenerative or post-traumatic or rheumatoid arthrosis, avascular onecrosis fracture of the femoral head or fracture of the femoral neck, after a previous surgical intervention, after osteosynthesis, reconstruction of the joint, arthrodesis, hemiarthroplasty or total hip replacement, post-traumatic coxarthrosis, coxarthrosis in mild osteoporosis, pathological osteoporosis, pronounced osteoporosis, revisions with slight loss of bone, extensive osseous bone reviews, fracture revisions
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.