The Recall Desk
ModerateFDA (Devices)·Z-0113-2022·Announced 2021-10-20

Flower Drill Bit Kit Missing AO Connect Feature, May Delay Procedures

Flower Orthopedics Corporation is recalling Flower Drill Bit Kit 2.7mm (DBK 027) due to missing AO connect feature that may delay surgical procedures. Affected kits were distributed across multiple U.S. states.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall of a surgical instrument with a missing feature. No injuries, illnesses, or hospitalizations have been reported. The stated consequence is potential procedural delay rather than direct patient harm.

Plain-English summary

Flower Orthopedics Corporation is recalling the Flower Drill Bit Kit 2.7mm (Catalog Number DBK 027) because the drill bits packaged in affected kits are missing the AO connect feature. This feature is necessary for compatibility with certain surgical systems. The absence of this feature may result in delay of surgical procedures.

The recalled kits are identified by Lot Numbers 2013003588 and 2013004613. Three units were involved in this recall. The affected kits were distributed to healthcare facilities in Arizona, California, Colorado, Florida, Illinois, Indiana, Nevada, Ohio, Texas, and Virginia.

Healthcare providers and facilities who have received the recalled kits should contact Flower Orthopedics Corporation for information regarding replacement or corrective action for their specific units.

The recalled product

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
Manufacturer
Flower Orthopedics Corporation
Hazard
  • missing-feature

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 (2)

  • Lot Number: 2013003588
  • 2013004613 Unique Identifier: 00840118101295

Distribution

Distribution scope not specified by the agency.