The Recall Desk
ModerateFDA (Devices)·Z-0114-2022·Announced 2021-10-20

Flower Lag Screw Kit drill bits missing AO connect feature recalled

Flower Orthopedics is recalling Flower Lag Screw Kit 2.7 mm because drill bits lack the AO connect feature, which may delay surgical procedures.

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: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a missing functional feature that may cause procedural delay rather than direct patient harm.

Plain-English summary

Flower Orthopedics Corporation is recalling Flower Lag Screw Kit 2.7 mm (Catalog Number LSK 027) due to drill bits missing the AO connect feature. The affected kits are intended for use with various Flower orthopedic plating sets including the Small and Medium Implant Set, Ankle Plating Set, Rear Foot/Calcaneus Plating Set, and Upper Extremity Plating Set.

The missing AO connect feature on the drill bits may result in delay of surgical procedures. The affected lot number 2013003419 was distributed to healthcare facilities in Arizona, California, Colorado, Florida, Illinois, Indiana, Nevada, Ohio, Texas, and Virginia.

Healthcare providers using this product should contact Flower Orthopedics Corporation regarding replacement or corrected kits. No injuries or illnesses related to this issue have been reported.

The recalled product

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 med
Manufacturer
Flower Orthopedics Corporation
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: 2013003419 Unique Identifier: 00840118103688

Distribution

Distribution scope not specified by the agency.