medical Class II Updated 2020-08-19

Flower Orthopedics Corporation recalls Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF

Recalled Product

Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number 1909660033; UDI 00840118115667
View official government recall

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