Flower Drill Bit Kit 2.0 mm - intended to be used with… recallZ-0111-2022 · Flower Orthopedics Corporation · initiated Sep 1, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Flower Orthopedics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
FDA root cause category: Packaging change control
What the company is doing
Coventus Orthopedic issued email communication on 9/01/21. Letter states reason for recall, health risk and action to take: Check your inventory for the product listed below. Next, please complete and return the attached Acknowledgement and Receipt Form by Friday, September 10, 2021. If you indicate on the form that you are in possession of affected product, Conventus Flower will ask that you return that affected kits. Conventus Flower will send replacement product as soon as we receive your completed Acknowledgement and Receipt Form. New DBK 020, DBK 024, DBK 027, or LSK 027 kits will be shipped to customers to replace affected product once the Acknowledgement and Receipt Form is received. Other Information: "Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or [email protected]
Recall details
- Recall number
- Z-0111-2022
- Status
- Terminated
- Initiated by the company
- Sep 1, 2021
- Recalling firm
- Flower Orthopedics Corporation
- Quantity
- 2 units
- Product code
- HTW
- Distribution
- Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia
Product description
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
Code information (models, lots, serial numbers)
Lot Number: 2013002721, 2013003589 Unique Identifier: 00840118101264
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Drill Bit Kit, 2.0mm DBK 020Flower Orthopedics Corporation · Bit, Drill1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 88669).
- Z-0112-2022 · TerminatedFlower 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 lockin…
- Z-0113-2022 · TerminatedFlower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flo…
- Z-0114-2022 · TerminatedFlower 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 S…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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