Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of… recallZ-0034-2022 · Flower Orthopedics Corporation · initiated Sep 3, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Flower Orthopedics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
FDA root cause category: Under Investigation by firm
What the company is doing
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]
Recall details
- Recall number
- Z-0034-2022
- Status
- Terminated
- Initiated by the company
- Sep 3, 2021
- Recalling firm
- Flower Orthopedics Corporation
- Quantity
- 77 kits
- Product code
- HRS
- FDA submissions
- K123562
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
Product description
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Code information (models, lots, serial numbers)
Lot Number: 2104321637 Unique Identifier: 00840118112079
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Flower E-Kit, Advanced EWK 201Flower Orthopedics Corporation · Pin, Fixation, Smooth1 recall0 reports
Other devices under the same FDA submission
8 devices cleared under K123562 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Distal Radius Plate, Standard, Left, 3 Holes FDR 011Flower Orthopedics Corporation · Plate, Fixation, Bone2 reports
- Variable Angle Locking Screw FRP 316Flower Orthopedics Corporation · Screw, Fixation, Bone1 report
- Variable Angle Locking Screw FRP 318Flower Orthopedics Corporation · Screw, Fixation, Bone1 report
- Distal Radius Plate, Dorsal (R), 9 Holes FRP 432Flower Orthopedics Corporation · Plate, Fixation, Bone1 report
- Variable Angle Locking Screw FLP 322Flower Orthopedics Corporation · Screw, Fixation, Bone1 report
- Variable Angle Locking Screw FLP 326Flower Orthopedics Corporation · Screw, Fixation, Bone1 report
- Variable Angle Locking Peg FDR 118Flower Orthopedics Corporation · Screw, Fixation, Bone1 report
- Variable Angle Locking Peg FDR 120Flower Orthopedics Corporation · Screw, Fixation, Bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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