Flower Orthopedics Corporation Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Brand
Flower Orthopedics Corporation
Lot Codes / Batch Numbers
Lot Number: 2104321637 Unique Identifier: 00840118112079
Products Sold
Lot Number: 2104321637 Unique Identifier: 00840118112079
Flower Orthopedics Corporation is recalling Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 due to Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
Recommended Action
Per FDA guidance
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 FLOWERCS@FLOWERORTHO.COM
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026