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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.
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 ...
Orthopedic implant example seen with X-ray. An orthopedic implant is a medical device manufactured to replace a missing joint or bone, or to support a damaged bone. [1] The medical implant is mainly fabricated using stainless steel and titanium alloys for strength and the plastic coating that is done on it acts as an artificial cartilage. [2]
Failure of a dental implant is often related to the failure of the implant to osseointegrate correctly with the bone, or vice versa. [4] A dental implant is considered to be a failure if it is lost, mobile or shows peri-implant (around the implant) bone loss of greater than 1.0 mm in the first year and greater than 0.2 mm a year after. [5]
On February 10, 2011, the U.S. FDA issued an advisory on metal-on-metal hip implants, stating it was continuing to gather and review all available information about metal-on-metal hip systems. [67] On June 27–28, 2012, an advisory panel met to decide whether to impose new standards, taking into account findings of the study in The Lancet.
Levonorgestrel-releasing implant prevents pregnancy through multiple methods: by preventing ovulation, which means that no eggs are released for fertilization; by thickening the mucus of the cervix, which prevents sperm from entering; and by thinning the lining of the uterus, which makes implantation of an embryo less likely.
The consumer healthcare company is recalling the cough syrup, sold under the brand name "Robitussin Honey CF Max Day Adult" in 4-ounce and 8-ounce doses, along with its 8-ounce night-time version.
That’s why Surf 9 recalled about 20,300 Body Glove Tandem and ULI inflatable paddle boards and supyaks sold exclusively at Costco warehouses across the United States and Canada. Over 20,000 ...