PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: October 20, 2021 Initiated: September 1, 2021 #Z-0112-2022

Product Description

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

Reason for Recall

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Details

Units Affected
33 units
Distribution
Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia
Location
Horsham, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Flower Orthopedics Corporation. Units affected: 33 units.
Why was this product recalled?
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Which agency issued this recall?
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0112-2022.