| Class 2 Device Recall Flower Drill Bit Kit 2.7mm | |
Date Initiated by Firm | September 01, 2021 |
Create Date | October 14, 2021 |
Recall Status1 |
Terminated 3 on February 16, 2023 |
Recall Number | Z-0113-2022 |
Recall Event ID |
88669 |
Product Classification |
Bit, drill - Product Code HTW
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Product | Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism.
Catalog Number: DBK 027 |
Code Information |
Lot Number: 2013003588, 2013004613 Unique Identifier: 00840118101295 |
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 |
Manufacturer Reason for Recall | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
FDA Determined Cause 2 | Packaging change control |
Action | Coventus Orthopedic issued email communication on 9/01/21. Letter states reason for recall, health risk and action to take:
Check your inventory for the product listed 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 affected product, Conventus Flower will ask that you return that affected kits. Conventus Flower will send replacement product as soon as we receive your completed Acknowledgement and Receipt Form.
New DBK 020, DBK 024, DBK 027, or LSK 027 kits will be shipped to customers to replace affected product once the Acknowledgement and Receipt Form is received.
Other Information:
"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 | 3 units |
Distribution | Arizona
California
Colorado
Florida
Florida
Illinois
Indiana
Nevada
Ohio
Texas
Virginia |
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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