The Recall Desk
HighFDA (Devices)·Z-0112-2022·Announced 2021-10-20

Flower Drill Bit Kit 2.4mm missing AO connect feature

Flower Orthopedics Corporation is recalling 33 units of its 2.4mm Drill Bit Kit (Lot 2101321194) because the drill bits lack the AO connect feature, which may delay surgical procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a surgical instrument with a missing component feature that may delay procedures. This is a risk-of-harm medical device where no injuries have been reported, meeting the criteria for High severity.

Plain-English summary

Flower Orthopedics Corporation is recalling the Flower Drill Bit Kit 2.4 mm (Catalog Number DBK 024), a surgical instrument used in orthopedic procedures. The recall affects 33 units with Lot Number 2101321194 (UDI: 00840118101288).

The drill bits in these kits are missing the AO connect feature, which is a critical component of the product's interface system. This defect may result in delays during surgical procedures.

The affected kits were distributed to healthcare facilities in Arizona, California, Colorado, Florida, Illinois, Indiana, Nevada, Ohio, Texas, and Virginia.

Healthcare facilities that received these kits should immediately discontinue use and contact Flower Orthopedics Corporation for replacement or recall instructions.

The recalled product

Product
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
Manufacturer
Flower Orthopedics Corporation
Category
Medical Device — Orthopedic Surgical Instruments
Hazard
  • missing-feature
  • procedure-delay

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 2101321194 Unique Identifier: 00840118101288

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category