FDAFDA · Food and drugs·Recall number Z-2787-2020
Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
Published August 19, 2020 · Recall initiated: July 8, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Flower Orthopedics Corporation
- Distributor
- US Nationwide distribution including in the states of AZ, FL, and OH.
- Lot
- Lot Number 1909660037; UDI 00840118115698
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.