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Flower Orthopedics Corporation recalls Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixat
Recalled August 19, 2020 · FDA recall Z-2783-2020 · Flower Orthopedics
Hazard
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). · FDA Class II
Units
25
Sold at
US Nationwide distribution including in the states of AZ, FL, and OH.
Description
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Product
Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
Manufacturer(s)
Flower Orthopedics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →