FDA-Device2020-08-19Class II
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.
Flower Orthopedics Corporation
Hazard
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Sold states
US Nationwide distribution including in the states of AZ, FL, and OH.
Affected count
25
Manufactured in
100 Witmer Rd Ste 280, N/A, Horsham, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2784-2020Don't want to check this manually?
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