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

Agency Publication Date: August 12, 2020

Affected Products

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.

Lot Number 1909660028; UDI 00840118115643

Lot Numbers:

Number

Product: 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.

Lot Number 1909660029, 1909660031; UDI 00840118115650

Lot Numbers:

Number

Product: 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.

Lot Number 1909660033; UDI 00840118115667

Lot Numbers:

Number

Product: Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.

Lot Number 1909660034; UDI 00840118115674

Lot Numbers:

Number

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.

Lot Number 1909660035; UDI 00840118115681

Lot Numbers:

Number

Product: Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.

Lot Number 1909660037; UDI 00840118115698

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86023

Status: Resolved

Manufacturer: Flower Orthopedics Corporation

Manufactured In: United States

Units Affected: 6 products (25)

Agency Last Updated: August 13, 2020

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Lot Number 1909660028; UDI 00840118115643

Lot Numbers:

Number

Lot Number 1909660029, 1909660031; UDI 00840118115650

Lot Numbers:

Number

Lot Number 1909660033; UDI 00840118115667

Lot Numbers:

Number

Lot Number 1909660034; UDI 00840118115674

Lot Numbers:

Number

Lot Number 1909660035; UDI 00840118115681

Lot Numbers:

Number

Lot Number 1909660037; UDI 00840118115698

Lot Numbers:

Number