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U.S. Department of Health and Human Services

Class 2 Device Recall Coventus Flower

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  Class 2 Device Recall Coventus Flower see related information
Date Initiated by Firm September 03, 2021
Create Date October 06, 2021
Recall Status1 Terminated 3 on July 28, 2022
Recall Number Z-0034-2022
Recall Event ID 88724
510(K)Number K123562  
Product Classification Plate, fixation, bone - Product Code HRS
Product Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Code Information Lot Number: 2104321637 Unique Identifier: 00840118112079
Recalling Firm/
Manufacturer		 Flower Orthopedics Corporation
100 Witmer Rd Ste 280
Horsham PA 19044-2647
For Additional Information Contact same
215-394-8903
Manufacturer Reason
for Recall		 Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
FDA Determined
Cause 2		 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 in Commerce 77 kits
Distribution US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = FLOWER ORTHOPEDICS CORPORATION
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