FDA recall Z-0111-2022

Product

Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721

Reason for recall

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

Distribution

Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia

Key facts

Status

Terminated

Initiation date

2021-09-01

Report date

2021-10-20

Termination date

2023-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0111-2022