Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
This recall has been terminated (originally issued September 3, 2021).
- Company
- Flower Orthopedics Corporation
- Recall Initiated
- September 3, 2021
- Terminated
- July 28, 2022
- Recall Number
- Z-0034-2022
- Quantity
- 77 kits
- Firm Location
- Horsham, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
Distribution
US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
Lot / Code Info
Lot Number: 2104321637 Unique Identifier: 00840118112079
Root Cause
Under Investigation by firm
Action Taken
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