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Class 2 Device Recall Coventus Flower |
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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
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Product Classification |
Plate, fixation, bone - Product Code HRS
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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
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For Additional Information Contact |
same 215-394-8903
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Manufacturer Reason for Recall |
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
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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
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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.
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510(K) Database |
510(K)s with Product Code = HRS and Original Applicant = FLOWER ORTHOPEDICS CORPORATION
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