Loading…
ReNovo, Inc., a device reprocessor and distributor of reprocessed single-use medical devices including electrosurgical ablation wands, coblators, trocars, and surgical instruments, was cited for distributing adulterated devices without approved premarket approval (PMA) applications or investigational device exemptions as required under the Federal Food, Drug, and Cosmetic Act. The FDA inspection conducted May 15-18, 2023 at the company's Bend, Oregon facility identified multiple reprocessed device models that lacked the required regulatory authorizations for commercial distribution. The company's response to the FDA's initial inspection observations did not adequately address the agency's compliance concerns regarding the unauthorized distribution of these Class II and higher-risk medical devices.