FDA recall Z-0114-2022

Product

Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of 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: LSK 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-0114-2022