Medical device recalls Moderate risk

Flower Orthopedics Corporation recalls Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.

Recall date
December 22, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1113-2017
FDA classification
Class II
Brand / firm
Flower Orthopedics Corporation
Sold / distributed
Distributed throughout the United States

Why it was recalled

The product is being recalled due to incidence and reports of the product breaking during surgery.

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

What was recalled

Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.

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