Lower riskMedical device recall · FDA · Published September 3, 2021
Flower E-Kit Advanced Bone Fixation Kit Missing Critical Component
Flower Orthopedics recalls EWK 201 bone fixation kit missing CDG 200 component. This could lead to improper bone fixation. Affected units sold with lot number 2104321637.
“Flower E-Kit Advanced Bone Fixation Kit Missing Critical Component.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61833-flower-e-kit-advanced-bone-fixation-kit-missing-critical-component. Based on FDA recall #Z-0034-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0034-2022%22&limit=1).
Flower Orthopedics Corporation voluntarily recalled the Flower E-Kit, Advanced (Ref: EWK 201) on Sept. 3, 2021, according to the FDA. The Class II device is missing a Cannulated Countersink for 3.0-4.5mm Screws.
How to tell if you have it
Brand: Flower Orthopedics
Product: Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Lot Number: 2104321637
Unique Identifier: 00840118112079
The hazard
The product kit is missing the CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from the EWK 201 unit.
Context
GovInfoNow's records show Flower Orthopedics Corporation has five other recalls on record since July 8, 2020. Other recent recalls of similar products include a Flex-: Reamer recall (Aug. 29, 2023) and a Flex-Thread Inserter Shaft Recall (Nov. 2, 2021).
How to tell if you have this one
Check for the lot number 2104321637 on the kit's packaging. The product is labeled as 'Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201'.
Brand
Flower Orthopedics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Components
Verify that the kit includes the CDG 200 component (cannulated countersink for 3.0-4.5mm screws).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Nevada, New York, North Carolina, Ohio, Texas, West Virginia.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall indicates the kit may be missing a critical component, which could lead to improper bone fixation. However, the hazard level is low risk as the remedy does not require immediate discontinuation.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0034-2022 (September 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0034-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.