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.

Recall Insight

This FDA Devices action (record #Z-2783-2020) was formally reported on August 19, 2020, with the manufacturer initiating the action on July 8, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Flower Orthopedics Corporation is listed as the recalling firm, operating out of Horsham, PA. Federal records indicate 25 units are affected.

The documented reason for this recall is: The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of AZ, FL, and OH.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.