FDA Device recall Z-0448-2022
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in ord…
- FDA Device
- Class II
- terminated
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class II recall of Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in ord… by Flower Orthopedics, citing 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 comple….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0448-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-02 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Flower Orthopedics |
| Distribution | US |
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
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
Identifiers
| code_info | Lot Number: 11090 UDI: 00840118117548 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0448-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.