Z-0034-2022Class II

Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Name: Z-0034-2022 Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Creator: Flower Orthopedics Corporation
Published: 2021-09-03
License: https://open.fda.gov/license/

FLOWER ORTHOPEDICS Corporation dba Conventus Flower / initiated 2021-09-03 / Terminated

FDA source

Flower Orthopedics Corporation began a recall of Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 on 2021-09-03. FDA classified it as Class II and gives the reason as "Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0034-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-03
Posted: 2021-10-06
Terminated: 2022-07-28
Recalling firm: FLOWER ORTHOPEDICS Corporation dba Conventus Flower
Product: Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Product code: HRS Plate, Fixation, Bone
Reason for recall: Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
FDA root cause: Under Investigation by firm
Action: Coventus Flower Orthopedics issued letter dated 9/3/21 via email. Letter states reason fo recall, health risk and action to take: Check your inventory for the product listed below. Look into the see-through window in the box and determine if a CDG 200 is included. The CDG 200 resembles a pen and has a long, black handle and a silver tip. A photo of the CDG 200 is below: Next, please complete and return the attached Acknowledgement and Receipt Form by Friday, September 10, 2021. If you indicate on the form that you are in possession of an EWK 201 that is missing the CDG 200 component, Conventus Flower will ask that you return that affected kit. Conventus Flower will then send a replacement EWK 201 kit. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or [email protected]
Quantity in commerce: 77 kits
Distribution: US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
Product codes and lots: Lot Number: 2104321637 Unique Identifier: 00840118112079

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0034-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0034-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-06

Product code HRS

K123562Class IIFlower Small and Medium Bone ImplantsFlower Orthopedics Corporation / cleared 2013-03-29

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)