Flower E-Kit — Class II medical device recall Z-0034-2022
Terminated recall by Flower Orthopedics Corporation, reported 2021-10-13, distributed nationwide. Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced
| Recall number | Z-0034-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flower Orthopedics Corporation, Horsham, PA, United States |
| Recall initiated | 2021-09-03 |
| Classified | 2021-10-06 |
| Reported by FDA | 2021-10-13 |
| Terminated | 2022-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 77 kits |
| UPC / GTIN / UDI-DI | 00840118112079 |
| Lot numbers | 2104321637 |
| Model numbers | 201 |
Product
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Reason for recall
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
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-0034-2022. 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.