Recall Z-0112-2022 ยท HTW Bit, Drill
Flower Orthopedics Corporation
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
| Date | Sep 1, 2021 |
| Status | Terminated |
| Reason | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| Root cause | 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 sh |
| Quantity | 33 units |
| Distribution | Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.