Web23 feb. 2024 · Potential problems caused by Exactech’s recalled knee and ankle implants include: Accelerated wear, debris production, bone loss, component fatigue and … Web16 jan. 2012 · Smith & Nephew Journey-Deuce Uni Tibial Baseplates: Recalled in 2010 (40,000 units recalled) The baseplate (circled in red) rests on the tibia (the bottom leg bone), and attaches to the knee replacement hardware on the femur (the top leg bone). Because these baseplates are breaking, the entire knee replacement can become …
DePuy Synthes Attune Knee Recall and Lawsuit
Web26 apr. 2024 · In August 2024, medical device manufacturer Exactech ® recalled thousands of its knee and ankle replacement devices. The U.S. Food and Drug Administration (FDA) found that the devices, made with polyethylene inserts, may have been packaged in a way that exposed the inserts to too much oxygen. Web9 aug. 2024 · If you wish to find information on a recall, or a correction or removal action that has not yet been classified, you can search the Medical Device Recalls Database. Please note that the FDA lists ... literary agents for fairy tales
Experts Say FDA Should Abandon Approval Process - ABC News
Web16 jul. 2024 · The effectiveness of Persona in comparison to NexGen is currently being studied. Zimmer decided to recall a component of the Persona knee replacement system — the Persona Trabecular Metal Tibial Plate — after it became aware that the product was loosening after surgical implantation. In other words, the plate was not staying in place. Web4 sep. 2015 · The Class II recall was issued in August 2012. Between January 2011 and March 2014, the FDA received about 30 reports of spacer dislodgment or tibial tray loosening associated with the ConforMIS iTotal G2 Knee Replacement System. This caused its users a number of complications including immobility, bone damage, and the … WebMedical Device Recalls. This database contains Medical Device Recalls classified since November 2002. Since January 2024, it may also include correction or removal actions initiated by a firm prior to review by the FDA. The status is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is ... literary agents in boston ma