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Recall Observatory FDA recall evidence

Device 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.

Z-2782-2020

July 08, 2020

Class II

Product summary

Firm
Flower Orthopedics Corporation
Event
Event 86023
Status
Terminated
Classification
Class II
Quantity
25
Official record key
device-enforcement:Z-2782-2020

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 1909660028; UDI 00840118115643

Distribution pattern: US Nationwide distribution including in the states of AZ, FL, and OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).