Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material
Flower Orthopedics is recalling 25 calcaneus plates because they were manufactured with a titanium alloy instead of pure titanium.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard involves a material substitution (titanium alloy vs. pure titanium) without explicit mention of high-risk pathogens or structural failure leading to harm.
Plain-English summary
Flower Orthopedics Corporation is recalling 25 units of the Calcaneus Plate, Extensile, Medium, Left (Catalog Number CPF 102). The recall affects Lot Numbers 1909660029 and 1909660031, with UDI 00840118115650.
The contract manufacturer inadvertently used the incorrect material to manufacture the plates, utilizing a titanium alloy rather than pure titanium. The product is intended for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
The affected units were distributed nationwide in the United States, including in the states of Arizona, Florida, and Ohio. The FDA has classified this recall as Class II.
The recalled product
- 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.
- Manufacturer
- Flower Orthopedics Corporation
- Hazard
- Affected units
- 25
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Number 1909660029
- 1909660031
- UDI 00840118115650
Distribution
Part of a larger recall action
This product is one of 6 recalled by Flower Orthopedics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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