Flower Orthopedics Corporation Recall 89092
Description: 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
Flower Orthopedics Corporation Recall 89092 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0448-2022 |
| Event ID | 89092 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX. |
| Quantity | 48 units |
| Recall 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 |
| Device Classification | 20220112 |
| Device Code Info | Lot Number: 11090 UDI: 00840118117548 |
| Center Classification Date | 20220103 |
| Recall Initiation Date | 20211102 |
| Recalling Firm | Flower Orthopedics Corporation |
| Initial Notification | Letter |
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