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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any injuries, illnesses, or deaths, and the hazard is a material specification error rather than a high-risk pathogen or structural failure with reported harm.
Plain-English summary
Flower Orthopedics Corporation is recalling 25 units of the Calcaneus Plate, Extensile, Small, Left (Catalog Number CPF 101). The recall affects Lot Number 1909660028 and UDI 00840118115643. These medical devices are 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 products were distributed nationwide in the United States, including in the states of Arizona, Florida, and Ohio.
Consumers and healthcare providers should stop using the affected devices and contact Flower Orthopedics Corporation for further instructions on how to return or dispose of the product.
The recalled product
- 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.
- 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 1909660028
- UDI 00840118115643
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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