The Recall Desk
SevereFDA (Devices)·Z-1113-2017·Announced 2017-02-08

Flower Orthopedics Recalls Cannulated Drill Bits Due to Breakage During Surgery

Flower Orthopedics Corporation is recalling 2.0mm and 2.6mm cannulated drill bits because they have broken during surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device used during surgery, which poses a significant risk of injury to patients.

Plain-English summary

Flower Orthopedics Corporation is recalling 2.0mm and 2.6mm cannulated drill bits. These devices are used in conjunction with the Flower Bone Screw Set.

The recall was initiated due to reports of the drill bits breaking during surgical procedures. The devices were distributed throughout the United States.

Healthcare providers should stop using the affected drill bits and contact the manufacturer for further instructions.

The recalled product

Product
Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.

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)

  • Device Listing: D267957

Distribution

Distribution scope not specified by the agency.