CLASS II Device recall · Reported 20 Oct 2021 · FDA Enforcement Report
Flower Drill Bit Kit-intended to be used recalled by Flower Orthopedics
Flower Orthopedics is recalling Flower Drill Bit Kit-intended to be used with solid screws and can be used with any plate, distributed in 10 states. The recall was initiated on 1 Sep 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0112-2022
- FDA event ID
- 88669
- Recalling firm
- Flower Orthopedics, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Sep 2021
- FDA classified
- 13 Oct 2021
- Reported
- 20 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 1 Sep 2021 | Recall initiated by company | |
| 13 Oct 2021 | Classified by FDA | +42 days |
| 20 Oct 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia
ArizonaCaliforniaColoradoFloridaIllinoisIndianaNevadaOhioTexasVirginia
Questions about this recall
Is Flower Drill Bit Kit-intended to be used with solid screws and can be used with any plate recalled?
Yes. Flower Orthopedics recalled Flower Drill Bit Kit-intended to be used with solid screws and can be used with any plate on 1 Sep 2021. The recall is Class II and its status is Terminated. Recall number Z-0112-2022.
Why was it recalled?
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Which lots are affected?
Lot Number: 2101321194 Unique Identifier: 00840118101288
Where was it sold?
Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Flower Orthopedics
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Coventus Flower Orthopedics Flex-Thread TM Cannulated recalled | Flower Orthopedics | Sterility | Nationwide |
| Device | CLASS II | Flex-Thread Inserter Shaft intended recalled by Flower Orthopedics | Flower Orthopedics | Other | Nationwide |
| Device | CLASS II | Flower Drill Bit Kit- The Drill Bit Kit recalled by Flower Orthopedics | Flower Orthopedics | Packaging Defects | 10 states |
| Device | CLASS II | Flower Lag Screw Kit-intended to be used with lag screws recalled | Flower Orthopedics | Packaging Defects | 10 states |
| Device | CLASS II | Flower Drill Bit Kit - intended to be used recalled | Flower Orthopedics | Packaging Defects | 10 states |
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