Skip to content
Recall Observatory FDA recall evidence

Device 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

Z-0113-2022

September 01, 2021

Class II

Product summary

Firm
Flower Orthopedics Corporation
Event
Event 88669
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-0113-2022

Official wording

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

Code information: Lot Number: 2013003588, 2013004613 Unique Identifier: 00840118101295

Distribution pattern: Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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