Medical device recalls Moderate risk

Flower Orthopedics Corporation recalls 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…

Recall date
September 1, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0111-2022
FDA classification
Class II
Brand / firm
Flower Orthopedics Corporation
Sold / distributed
Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia

Why it was recalled

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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