Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Flower Orthopedics Corporation is recalling 25 units of the Calcaneus Plate, Extensile, Medium, Right (Catalog Number CPF 202). The product is intended for the 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 are identified by Lot Number 1909660035 and UDI 00840118115681. These products were distributed nationwide in the United States, including in the states of Arizona, Florida, and Ohio.
The recalled product
- 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.
- 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 1909660035
- UDI 00840118115681
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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