Coventus Flower Orthopedics Flex-Thread TM 3 — Class II medical device recall Z-0074-2024
Ongoing recall by Flower Orthopedics Corporation, reported 2023-10-18, distributed nationwide. Device is breaking while in use, potential for patients to require a revision surgery.
| Recall number | Z-0074-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flower Orthopedics Corporation, Horsham, PA, United States |
| Recall initiated | 2023-08-29 |
| Classified | 2023-10-06 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 70 units |
| UPC / GTIN / UDI-DI | 00840118117432 |
| Lot numbers | 2304323076 |
| Model numbers | 8528-1-S |
Product
Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S
Reason for recall
Device is breaking while in use, potential for patients to require a revision surgery.
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-0074-2024. 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.