Flower Orthopedics Corporation 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Flower Orthopedics Corporation
Lot Codes / Batch Numbers
UDI:00840118117432 Lot Number: 2304323076
Products Sold
UDI:00840118117432 Lot Number: 2304323076
Flower Orthopedics Corporation is recalling Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently ope due to Device is breaking while in use, potential for patients to require a revision surgery.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device is breaking while in use, potential for patients to require a revision surgery.
Recommended Action
Per FDA guidance
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 crovaldi@flowerortho.com. For further information contact Christina Rovaldi, Sr. Manager RA/QA crovaldi@flowerortho.com. Return the attached Acknowledgement and Receipt Form mail or by email to crovaldi@flowerortho.com. Company contact hours are Monday through Friday, 8:30 AM to 5:00 PM, Eastern Time
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026