Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage
Flower Orthopedics is recalling 25 calcaneus plates because the manufacturer used 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, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score involving low-risk contamination or material errors without reported harm.
Plain-English summary
Flower Orthopedics Corporation is recalling 25 units of the Calcaneus Plate, Extensile, Large, Left (Catalog Number CPF 103). The product is intended for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
The recall was initiated because the contract manufacturer inadvertently used the incorrect material to manufacture the plates. Specifically, a titanium alloy was used rather than pure titanium.
The affected units were distributed nationwide in the United States, including in the states of Arizona, Florida, and Ohio. The specific lot number is 1909660033 and the UDI is 00840118115667.
The recalled product
- 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.
- 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 (2)
- Lot Number 1909660033
- UDI 00840118115667
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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