FDA recall Z-0113-2022

Product

Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027

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-0113-2022