Device product
Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
Z-2786-2020
Product summary
- Event
- Event 86023
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25
- Official record key
device-enforcement:Z-2786-2020
Official wording
Reason: The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Code information: Lot Number 1909660035; UDI 00840118115681
Distribution pattern: US Nationwide distribution including in the states of AZ, FL, and OH.
Derived failure modes
-
Unknown
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).