Flower Drill Bit Kit missing AO connect feature may delay procedures
Flower Orthopedics is recalling Flower Drill Bit Kit 2.0 mm kits because drill bits are missing the AO connect feature, which may result in procedural delays. Affected units were distributed across multiple 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 Class II recall involves a functional defect in a surgical device with no reported injuries or illnesses. The stated consequence is procedural delay rather than direct patient safety harm. Per the rubric, recalls with no reported illness and theoretical rather than realized harm are classified as Moderate.
Plain-English summary
Flower Orthopedics Corporation is recalling Flower Drill Bit Kit 2.0 mm due to a manufacturing defect. The drill bits in affected kits are missing the AO connect feature, which is required for proper use with compatible orthopedic implant systems.
The missing feature may result in delay of surgical procedures if discovered during use. The recalled kits were distributed to healthcare facilities in Arizona, California, Colorado, Florida, Illinois, Indiana, Nevada, Ohio, Texas, and Virginia.
Healthcare providers who have received these kits should verify that drill bits include the AO connect feature before use. If the feature is missing, contact the manufacturer for replacement or guidance. Patients scheduled for orthopedic procedures should consult with their healthcare provider if they have concerns about equipment preparation.
The recalled product
- Product
- Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
- Manufacturer
- Flower Orthopedics Corporation
- Hazard
- device-malfunction
- 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: 2013002721
- 2013003589 Unique Identifier: 00840118101264
Distribution
Distribution scope not specified by the agency.
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