Class II — Flower Orthopedics Corporation
| Recalling firm | FLOWER ORTHOPEDICS CORPORATION |
|---|---|
| Registered facility | FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower (the firm's only registered facility) |
| Classification | Class II |
| 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 |
| Product | 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 |
| Quantity | 48 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX. |
| Initiated | 2021-11-02 |
| Classified | 2022-01-03 |
| Terminated | 2023-10-12 |
| Recall number | Z-0448-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Flower Orthopedics Corporation (Z-0448-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89092/
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