Flower Orthopedics Corporation recalls Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixa…

Recall date

July 8, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2785-2020

FDA classification

Class II

Brand / firm

Flower Orthopedics Corporation

Sold / distributed

US Nationwide distribution including in the states of AZ, FL, and OH.

Why it was recalled

The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).

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

What was recalled

Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.