Z-0112-2022Class II

Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as...

Name: Z-0112-2022 Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as...
Creator: Flower Orthopedics Corporation
Published: 2021-09-01
License: https://open.fda.gov/license/

FLOWER ORTHOPEDICS Corporation dba Conventus Flower / initiated 2021-09-01 / Terminated / root cause: packaging

FDA source

Flower Orthopedics Corporation began a recall of 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... on 2021-09-01. FDA classified it as Class II and gives the reason as "Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0112-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-01
Posted: 2021-10-14
Terminated: 2023-02-16
Recalling firm: FLOWER ORTHOPEDICS Corporation dba Conventus Flower
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
Product code: HTW Bit, Drill
Reason for recall: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Root cause tag: packaging
FDA 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 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 [email protected]
Quantity in commerce: 33 units
Distribution: Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia
Product codes and lots: Lot Number: 2101321194 Unique Identifier: 00840118101288

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0112-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0111-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0112-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0113-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0114-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13

Product code HTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)