Z-2784-2020 Class II Terminated
FDA device recall Z-2784-2020 was initiated by Flower Orthopedics Corporation on July 8, 2020 and is designated Class II. 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). The recall status is terminated (terminated October 8, 2020). Affected quantity: 25.
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, 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.
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 1909660033; UDI 00840118115667