Flex-Thread Inserter Shaft intended for Fibula… — Class II medical device recall Z-0448-2022
Terminated recall by Flower Orthopedics Corporation, reported 2022-01-12, distributed nationwide. Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to b
| Recall number | Z-0448-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flower Orthopedics Corporation, Horsham, PA, United States |
| Recall initiated | 2021-11-02 |
| Classified | 2022-01-03 |
| Reported by FDA | 2022-01-12 |
| Terminated | 2023-10-12 |
| Distributed | Nationwide (US) |
| Quantity | 48 units |
| UPC / GTIN / UDI-DI | 00840118117548 |
| Lot numbers | 11090 |
| Model numbers | 8435-1 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0448-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.