http://badmedicaldevicesblog.com Just another WordPress weblog Wed, 08 Sep 2010 20:42:30 +0000 http://backend.userland.com/rss092 en Johnson & Johnson's DePuy Orthopaedics has said patients fitted with faulty hip replacements must hand over the faulty hip device and related medical records if the medical devices company is to pay for repair surgery. The device at the centre of the controversy is the DePuy ASR AX acetabular system, which ... http://badmedicaldevicesblog.com/2010/09/08/johnson-johnsons-depuy-unit-places-conditions-of-recalled-hip-device-repair/ Johnson & Johnson has been sued by a California construction worker over an implanted hip-replacement device that the drugmaker stopped selling last month after defect reports surfaced. The suit alleged officials of J&J’s DePuy Othropaedics unit knew for years many of the 93,000 patients with ASR hip implants required corrective surgeries ... http://badmedicaldevicesblog.com/2010/09/08/j0hnson-johnson-sued-over-recalled-hip-replacement-devices/ A Rhode Island jury has awarded $1.5 million to two people who suffered injuries as a result of the defective Composix® Kugel® Mesh hernia repair patch. The jury agreed with the attorneys for Christopher and Laure Thorpe that a defective design of the hernia patch manufactured by Davol Inc. and C.R. ... http://badmedicaldevicesblog.com/2010/09/01/rhode-island-jury-awards-15-million-for-kugel-mesh-patch-injuries/ The FDA is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device. Use of the tanning device can lead to an overdose of ultraviolet radiation because its labeling recommends an improper duration of exposure to radiation and the device has an inadequate timer; ... http://badmedicaldevicesblog.com/2010/08/30/portable-foot-tanning-device-recalled-by-fda/ Johnson & Johnson's DePuy Orthopaedics unit has recalled two hip joint replacement parts because they are likely to lead to a second surgery. According to an AP report, the products included in the recall are the ASR Hip Resurfacing System and the ASR XL Acetabular System. J&J announced the recall ahead of ... http://badmedicaldevicesblog.com/2010/08/27/johnson-johnson-recalls-two-asr-hip-replacement-parts-due-to-failure-rates/ The Food and Drug Administration has issued two separate Class I recalls on Straight and Right-Angle Huber needles because they pose risks of serious injuries or death to patients. According to a release from the FDA, the recall includes the following products manufactured by Multi-Med: * 22 ... http://badmedicaldevicesblog.com/2010/08/27/fda-issues-class-i-recalls-on-two-huber-needles-due-to-coring-risk/ The Food and Drug Administration has warned Johnson & Johnson about its marketing practices for two popular medical devices. According to a report from AOL's DailyFinance.com, the warning letter demands J&J and its subsidiaries stop marketing the TruMatch Personalized Solutions System - a 3-D scanner used prior to knee implant surgery ... http://badmedicaldevicesblog.com/2010/08/26/fda-warns-jj-over-marketing-of-two-devices/ Johnson & Johnson has been forced to recall millions of contact lenses in Asia and Europe because customers have been complaining of a stinging in the eye when inserting them for the first time. The recall covers about 100,000 boxes (30-90 lenses per box) of 1-Day Acuvue TruEye contact lenses. It ... http://badmedicaldevicesblog.com/2010/08/24/jj-recalls-1-day-acuvue-contact-lenses-in-japan-europe/ Two nuclear breast scans may actually increase the risk of developing radiation-induced cancer among women. According to a report published in an online version of the journal Radiology, researchers at University of Colorado's Denver School of Medicine found two specific nuclear breast scans carry a lifetime risk of fatal cancer greater ... http://badmedicaldevicesblog.com/2010/08/24/nuclear-breast-scans-carry-increased-risk-of-fatal-radiation-cancers/ The Food and Drug Administration has forced St. Jude Medical to issue a Class I recall six French Engage Introducers because they can malfunction during use and cause a life-threatening situation. The Engage Introducer is used to implant catheters and electrodes into blood vessels during surgery and helps to prevent blood ... http://badmedicaldevicesblog.com/2010/08/16/possible-deadly-defects-forces-st-jude-medical-to-recall-engage-introducer-medical-device/