Recall Z-0448-2022 ยท HSB Rod, Fixation, Intramedullary And Accessories
Flower Orthopedics Corporation
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
| Date | Nov 2, 2021 |
| Status | Terminated |
| Reason | Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available |
| Root cause | Device Design |
| Action | Conventus Flower Orthopedics issued Urgent Recall Information letter dated 11/2/21 stating reason for recall, health risk and action to take: Check your inventory for the product listed below and immediately replace with the new product provided. 2.Next, please complete and return the attached Acknowledgement and ReceiptForm with the affected product in the provided packaging by November 5, 2021. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or FLOWERCS@FLOWERORTHO.COM |
| Quantity | 48 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX. |
| 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 |