Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary
FDA device recall Z-0074-2024 · posted 2023-10-06 · Open, Classified
Recall details
- Recalling firm
- Flower Orthopedics Corporation
- Reason for recall
- Device is breaking while in use, potential for patients to require a revision surgery.
- 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
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- HSB
- Quantity affected
- 70 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-08-29
- Date posted
- 2023-10-06
- Location
- Horsham, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Flex-ThreadTM Distal Fibula Intramedullary Nail System (K202858) | Conventus Orthopaedics, LLC | 2021-01-22 |