Recall Z-0034-2022 ยท HRS Plate, Fixation, Bone
Flower Orthopedics Corporation
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
| Date | Sep 3, 2021 |
| Status | Terminated |
| 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 |
| Quantity | 77 kits |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123562 | FLOWER SMALL AND MEDIUM BONE IMPLANTS Flower Orthopedics Corporation, Mar 29, 2013 |