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.
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
Flower Orthopedics is recalling their EWK 201 Advanced Bone Fixation Kit because it may be missing a critical component (CDG 200) needed for proper bone fixation. This could result in improper healing or complications if the kit is used without the missing part.
The kit may be missing the CDG 200 component, which is a cannulated countersink for screws. Without this part, the bone fixation may not be secure, potentially leading to improper healing or complications during surgery.
People who purchased the Flower E-Kit Advanced Bone Fixation Kit (EWK 201) with lot number 2104321637 are affected. Patients undergoing orthopedic surgery are most at risk if the kit is used without the missing component.
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'.
Verify that the kit includes the CDG 200 component (cannulated countersink for 3.0-4.5mm screws).
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.
Check if your kit includes the CDG 200 component. If missing, contact Flower Orthopedics for guidance.
Affected kits have lot number 2104321637 and are labeled as 'Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201'.
We’ve drafted a message you can send Flower Orthopedics to request your refund or repair — edit it as you like.
Subject: Recall Z-0034-2022 — Flower Orthopedics Flower Orthopedics Hello, I own a Flower Orthopedics that is covered by recall Z-0034-2022 from Flower Orthopedics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
