Recall Z-0074-2024 ยท HSB Rod, Fixation, Intramedullary And Accessories
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
| Date | Oct 6, 2023 (initiated Aug 29, 2023) |
| Status | Open, Classified |
| Reason | Device is breaking while in use, potential for patients to require a revision surgery. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 70 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System Conventus Orthopaedics, LLC, Jan 22, 2021 |