Z-2783-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2020
- Initiation Date
- July 8, 2020
- Termination Date
- October 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25
Product Description
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.
Reason for Recall
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Distribution Pattern
US Nationwide distribution including in the states of AZ, FL, and OH.
Code Information
Lot Number 1909660029, 1909660031; UDI 00840118115650