FDA Medical Device Recalls (openFDA)
Flower Orthopedics Corporation: Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
- Recall number
- Z-0034-2022
- Recalling firm
- Flower Orthopedics Corporation
- Product
- Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
- Status
- Terminated
- Initiated
- 2021-09-03
- Posted
- not on file
- Terminated
- 2022-07-28
- Reason
- Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
- 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 FLOWERCS@FLOWERORTHO.COM
- Quantity
- 77 kits
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
- Lot, serial or model codes
- Lot Number: 2104321637 Unique Identifier: 00840118112079
- 510(k) numbers
- ["K123562"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3009996260
- Firm city
- Horsham
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28