FDA Device recall Z-0034-2022
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
- FDA Device
- Class II
- terminated
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 by Flower Orthopedics, citing product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0034-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-03 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Flower Orthopedics |
| Distribution | US |
Product
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Reason
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
Identifiers
| code_info | Lot Number: 2104321637 Unique Identifier: 00840118112079 |
|---|
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-0034-2022%22
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