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U.S. Department of Health and Human Services

Class 2 Device Recall Flower Drill Bit Kit 2.4mm

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  Class 2 Device Recall Flower Drill Bit Kit 2.4mm see related information
Date Initiated by Firm September 01, 2021
Create Date October 14, 2021
Recall Status1 Terminated 3 on February 16, 2023
Recall Number Z-0112-2022
Recall Event ID 88669
Product Classification Bit, drill - Product Code HTW
Product Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism.
Catalog Number: DBK 024
Code Information Lot Number: 2101321194 Unique Identifier: 00840118101288
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		 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 33 units
Distribution Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia
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.
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