Recall Z-0074-2024
Flower Orthopedics Corporation · initiated August 29, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: UDI:00840118117432 Lot Number: 2304323076
Reason for recall
Device is breaking while in use, potential for patients to require a revision surgery.
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-0074-2024
- Initiated
- August 29, 2023
- Posted by FDA
- October 6, 2023
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 70 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Flower Orthopedics Corporation, Horsham, PA