Recalls In Brief
This article was originally published in The Gray Sheet
Synthes recall: Firm is recalling Synex II Central Body components used in its Synex II modular vertebral body replacement system after receiving reports of moderate to severe loss in device height six to 15 months after implantation. The Class I recall could pose "an imminent hazard" to patients, Synthes says, including neural injury, increased pain, spinal kyphosis (a curving of the spine), failure of supplementary fixation, or the need for revision surgery. The firm initiated the global recall Sept. 14, urging surgeons and hospitals to stop implanting the devices and to annually monitor implanted patients through radiographs and pain assessments
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Device registration and listing guidance: New 1guidance explains device facility registration and listing procedures established by the FDA Amendments Act of 2007. Since October 2007, domestic device companies and foreign firms that manufacture or process a device sold in the U.S. have had to register and pay an annual facility registration fee for all their establishments, unless a waiver is granted. The Oct. 8 guidance explains the new, online registration and listing process, and the process for requesting a waiver. Registration is complete once the fee is paid, information is submitted online and the company receives notice from FDA. The registration fee for fiscal 2010 is $2,008, rising to $2,179 in FY 2011 and $2,364 in 2012
510(k) database update: Agency's device center plans to issue proposed regulations that would allow FDA to update the 510(k) database to identify the current holder of a 510(k), according to Heather Rosecrans, director of CDRH's 510(k) staff. Unlike the PMA database, the 510(k) database currently is not updated when ownership of a 510(k) is sold or transferred to another firm. The regulations "have been drafted, and I hope that very soon those will be out," said Rosecrans
With finite resources, the UK’s regulatory agency responsible for health care products is rapidly addressing COVID-19 medtech issues. But shifting its focus will cause delays elsewhere.