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 Fl
Summary
The FDA issued a Class II for Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can by Flower Orthopedics Corporation. Reason: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure.
Details
Source
Device Recall
External ID
Z-0112-2022
Action Date
2021-10-20
Status
Terminated
Category
device
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
Lot/Code Info: Lot Number: 2101321194 Unique Identifier: 00840118101288
Quantity Affected: 33 units
Reason for Recall
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Distribution
Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-01
Company
Horsham, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 174 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Flower Orthopedics Corporation has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Flower Orthopedics Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Flower Orthopedics Corporation have FDA actions?
Flower Orthopedics Corporation has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0112-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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