Severity
Moderate
FDA Devices recall · Reported October 20, 2021
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Flower Orthopedics Corporation recalled Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used w… - a moderate-severity action.
Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used w… was recalled by Flower Orthopedics Corporation in October 20, 2021. Reason: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure. Check the official notice for the remedy. Verify recall #Z-0112-2022 with the FDA Devices before acting.
The recall
Flower Orthopedics Corporation issued this moderate-severity FDA Devices recall-Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure.
Sourced from official FDA Devices enforcement records. Verify recall #Z-0112-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0112-2022) was formally reported on October 20, 2021, with the manufacturer initiating the action on September 1, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Flower Orthopedics Corporation is listed as the recalling firm, operating out of Horsham, PA. Federal records list the affected scope as 33 units.
The documented reason for this recall is: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Distribution data in the federal record shows the product reached: Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
33 units
Related Recalls
6
3 from same agency
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
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0112-2022 |
| Date reported | October 20, 2021 |
| Date initiated | September 1, 2021 |
| Recalling firm | Flower Orthopedics Corporation |
| Firm location | Horsham, PA |
| Affected scope | 33 units |
| Distribution | Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 20, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.