Michael Barbella, Managing Editor01.20.24
An FDA warning picked up the majority of pageviews on ODT's website this past week.
The agency generated more than 1,200 site views after issuing a safety communication about possible risks related to Equinoxe shoulder system devices that were packaged in defective bags. The FDA reported the defective bags were missing an oxygen barrier layer that protects the shoulder replacement implant from oxidation, which can degrade polyethylene over time. Oxidation can lead to faster device wear or failure, as well as component cracking or fracture, each possibly leading to further surgeries to replace or correct the Equinoxe implant. To date, Exactech declined to begin voluntary recall for Equinoxe shoulder implants packaged in the defective bags.
Trailing far behind the FDA warning was the limited market launch and first surgical cases for Paragon 28's Bun-Yo-Matic Lapidus clamp system for bunion surgery. The cases were completed in Orange County, Calif., and Seattle. Bun-Yo-Matic was designed to intraoperatively stimulate weight-bearing and allow compression before applying the hardware. The approach, according to the company, can offer more reproducible, efficient means to restore 3D foot alignment, while accommodating the surgeon’s preferred fixation method in Lapidus procedures.
Other traffic drivers this past week included new product debuts from Xenco, Arthrex, and Osso VR. The latter—through the Osso Academy—added five new modules to its virtual reality medical training library. The modules feature hyper-realistic content in multiple subspecialty areas.
Arthrex, meanwhile, gained favor with cybervisitors for launching a new patient-focused resource, TheNanoExperience.com, highlighting Nano arthroscopy's science and benefits; while Xenco Medical followed suit by debuting its TrabeculeX Continuum, an initative designed to create a bridge between orthobiologics and digital health.
The agency generated more than 1,200 site views after issuing a safety communication about possible risks related to Equinoxe shoulder system devices that were packaged in defective bags. The FDA reported the defective bags were missing an oxygen barrier layer that protects the shoulder replacement implant from oxidation, which can degrade polyethylene over time. Oxidation can lead to faster device wear or failure, as well as component cracking or fracture, each possibly leading to further surgeries to replace or correct the Equinoxe implant. To date, Exactech declined to begin voluntary recall for Equinoxe shoulder implants packaged in the defective bags.
Trailing far behind the FDA warning was the limited market launch and first surgical cases for Paragon 28's Bun-Yo-Matic Lapidus clamp system for bunion surgery. The cases were completed in Orange County, Calif., and Seattle. Bun-Yo-Matic was designed to intraoperatively stimulate weight-bearing and allow compression before applying the hardware. The approach, according to the company, can offer more reproducible, efficient means to restore 3D foot alignment, while accommodating the surgeon’s preferred fixation method in Lapidus procedures.
Other traffic drivers this past week included new product debuts from Xenco, Arthrex, and Osso VR. The latter—through the Osso Academy—added five new modules to its virtual reality medical training library. The modules feature hyper-realistic content in multiple subspecialty areas.
Arthrex, meanwhile, gained favor with cybervisitors for launching a new patient-focused resource, TheNanoExperience.com, highlighting Nano arthroscopy's science and benefits; while Xenco Medical followed suit by debuting its TrabeculeX Continuum, an initative designed to create a bridge between orthobiologics and digital health.