Medical Devices Archives - Page 18 of 27

CLR Medicals International Inc. Recalls Viscoelastic Products

November 26, 2013 By The FDA Leave a Comment

CLR Medicals International Inc. is recalling Viscocel and Viscocel Plus. This drug recall is in response to FDA findings of deficiencies in the Quality System regulations for Medical Device Manufacturers, 21 Code of Federal Regulation (CFR) Part 820 and lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce. The … [Read more...]

FDA Issues Warning about More Depakote Birth Defect Risk

May 15, 2013 By Candelaria Leave a Comment

After a new study linked Depakote and other valproate medications taken during pregnancy to an increased risk of autism and autism spectrum disorders, the FDA has decided to put its strongest warning for pregnancy associated complications on the drug, designating it pregnancy class X for migraine prevention, which means that the drug’s dangers … [Read more...]

FDA Warns of the Dangers of DMAA (Dimethylamylamine)

April 30, 2013 By Candelaria 1 Comment

The FDA has warned consumers not to take any dietary supplement containing the ingredient DMAA (dimethylamylamine, which goes by other names as well, listed below), which has been associated with numerous risks, including seizures, heart attack, and death. When asked by the FDA to stop using the ingredient, most companies complied. USPLabs … [Read more...]

FDA Classifies Stryker Corp. Shapematch Cutting Guides Recall as Class I

April 11, 2013 By The FDA Leave a Comment

Stryker Corporation (NYSE:SYK) announced today that its orthopaedic division has received notice that the U.S. Food and Drug Administration (FDA) has reviewed the voluntary recall of its ShapeMatch Cutting Guides and that it will be classified as a Class I recall. ShapeMatch Cutting Guides are intended to be used as patient specific surgical … [Read more...]

Stryker May Still Be In Denial When It Comes To Their Financial Exposure Related To Recalled Hips

April 11, 2013 By Jonathan Rosenfeld 4 Comments

In a press release to shareholders, Stryker estimated that the recall of its Rejuvenate and ABG II modular-neck hip replacements would cost between $190 million and $390 million but Stryker might be a little too optimistic for comfort. Johnson and Johnson has already spent $800 million on a similar recall and still faces litigation in over 10,000 … [Read more...]