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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Manufacturer
- Flower Orthopedics Corporation
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.
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