Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any ...
FDA Device Recall #Z-0112-2022 — Class II — September 1, 2021
Recall Summary
| Recall Number | Z-0112-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 1, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Flower Orthopedics Corporation |
| Location | Horsham, PA |
| Product Type | Devices |
| Quantity | 33 units |
Product Description
Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024
Reason for Recall
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Distribution Pattern
Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia
Lot / Code Information
Lot Number: 2101321194 Unique Identifier: 00840118101288
Other Recalls from Flower Orthopedics Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0074-2024 | Class II | Coventus Flower Orthopedics Flex-Thread TM 3.2m... | Aug 29, 2023 |
| Z-0448-2022 | Class II | Flex-Thread Inserter Shaft intended for Fibula... | Nov 2, 2021 |
| Z-0034-2022 | Class II | Flower E-Kit, Advanced-Bone Fixation Fasterner-... | Sep 3, 2021 |
| Z-0113-2022 | Class II | Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, ... | Sep 1, 2021 |
| Z-0114-2022 | Class II | Flower Lag Screw Kit 2.7 mm-intended to be used... | Sep 1, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.