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The recall came after data from a study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients. [3] Even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that may not be discovered for years.
DePuy Synthes (/ d ə ˈ p j uː /) is a franchise of orthopaedic and neurosurgery companies.Acquired by Johnson & Johnson in 1998, its companies form part of the Johnson & Johnson MedTech business segment.
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 FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...
Get answers to your AOL Mail, login, Desktop Gold, AOL app, password and subscription questions. Find the support options to contact customer care by email, chat, or phone number.
There have been 51 complaints, one death related to this recall and one reported injury, the FDA said. B. Braun Medical did not immediately respond to a Reuters request for comment.
Cochlear is a medical device company that designs, manufactures, and supplies the Nucleus cochlear implant, the Hybrid electro-acoustic implant and the Baha bone conduction implant. [ 3 ] Based in Sydney , Cochlear was formed in 1981 as a subsidiary of Nucleus with finance from the Australian government to commercialise the implants pioneered ...
The claim: Photo shows migrants leaving NYC for Canada ahead of Trump presidency. A Nov. 14 Facebook post (direct link, archive link) includes an image showing several people stepping off a bus ...