Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S

Device is breaking while in use, potential for patients to require a revision surgery.

Flowers initiated communication via email with a quarantine form on 08/29/2023. A notification packet detailing parameters of recall was issued on (09/1/2023) via certified mail. Letter states reason for recall, health risk and action to take: Immediately quarantine lot 2304323076 if not already segregated after quarantine notice sent on 08/28/2023. Return Product to Conventus Flower headquarters at 100 Witmer Rd Suite 280, Horsham, PA 19044. This advisory notice only includes the lot identified above. It does NOT affect other lots. You must acknowledge this notice by returning the attached Acknowledgement and Receipt Form by mail or by email at [email protected]. For further information contact Christina Rovaldi, Sr. Manager RA/QA [email protected]. Return the attached Acknowledgement and Receipt Form mail or by email to [email protected]. Company contact hours are Monday through Friday, 8:30 AM to 5:00 PM, Eastern Time