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The 2010 DePuy Hip Replacement Recall was instituted when DePuy Orthopaedics, Inc., a division of Johnson & Johnson, recalled its ASR XL Acetabular metal-on-metal hip replacement system on August 24, 2010. [1][2]
Hip replacement is a surgical procedure in which the hip joint is replaced by a prosthetic implant, that is, a hip prosthesis. [1] Hip replacement surgery can be performed as a total replacement or a hemi/semi(half) replacement. Such joint replacement orthopaedic surgery is generally conducted to relieve arthritis pain or in some hip fractures.
DePuy Synthes (/ dəˈpjuː /) is a franchise of orthopaedic and neurosurgery companies. Acquired by Johnson & Johnson in 1998, its companies form part of the Johnson & Johnson Medical Devices group. DePuy develops and markets products under the Codman, DePuy Mitek, DePuy Orthopaedics and DePuy Spine brands.
Hip resurfacing has been developed as a surgical alternative to total hip replacement (THR). The procedure consists of placing a cap (usually made of cobalt-chrome metal), which is hollow and shaped like a mushroom, over the head of the femur while a matching metal cup (similar to what is used with a THR) is placed in the acetabulum (pelvis socket), replacing the articulating surfaces of the ...
Right to repair is a legal right for owners of devices and equipment to freely modify and repair products such as automobiles, electronics, and farm equipment. Right to repair may also refer to the social movement of citizens putting pressure on their governments to enact laws protecting a right to repair. Common obstacles to repair include ...
The recall affected 103,000 cars and involved the replacement of a front radius strut in the front suspension assembly, addressing a risk that the component might break and render the car impossible to steer. The manufacturers stated they had replicated the alleged defect by driving the car into a solid kerb at between 10–15 mph (16–24 km/h).
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
The regulator issued warning letters to ByHeart Inc, Reckitt Benckiser Group's Mead Johnson Nutrition and Perrigo's Wisconsin unit. The FDA pulled up these companies for failing to establish ...