Flower Orthopedics Corporation Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
Brand
Flower Orthopedics Corporation
Lot Codes / Batch Numbers
Lot Number 1909660028, UDI 00840118115643
Products Sold
Lot Number 1909660028; UDI 00840118115643
Flower Orthopedics Corporation is recalling Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used due to The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pur. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Recommended Action
Per FDA guidance
The Regional Business Director notified the customer by telephone and informed them that there was an issue with the newly released calcaneus plates. The 6 units were requested to be returned to Flower Orthopedics.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026