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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

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

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Recalls In Brief

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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