The FDA announced on July 8, 2020, that Flower Orthopedics Corporation voluntarily recalled Calcaneus Plates due to manufacturing errors involving incorrect material composition. The agency classified the recall as Class II.
How to tell if you have it
- Brand: Flower Orthopedics
- Product: Calcaneus Plate, Extensile, Medium, Left
- Catalog Number: CPF 102
- Lot Numbers: 1909660029, 1909660031
- UDI: 00840118115650
- Quantity: 25 units
The hazard
The contract manufacturer inadvertently used a titanium alloy rather than pure titanium to manufacture the plates, according to FDA records. The device is intended for internal fixation of fractures and reconstruction of bones of the rearfoot.
Context
GovInfoNow's records show Flower Orthopedics Corporation has five other recalls on record since April 15, 2021. Other recent recalls of similar products include Clariance Elegance Cervical Plates Recall (Feb. 20, 2026), Howmedica Osteonics Recalls Orthopedic Implant Bushings Due to Oxidation Risk (July 30, 2026), and I.T.S. GmbH FR.O.H. Calcaneus Repair System: MRI Safety Risk (Jan. 23, 2026).