Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage
Flower Orthopedics is recalling 25 Calcaneus Plates, Extensile, Large, Right (Catalog Number CPF 203) because the contract manufacturer used 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. The hazard involves the use of a different titanium alloy rather than pure titanium, which is a material deviation without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Flower Orthopedics Corporation is recalling 25 units of the Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203. This medical device 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 1909660037 and UDI 00840118115698. The products were distributed nationwide in the United States, including in the states of Arizona, Florida, and Ohio. The source text does not specify further actions for consumers or healthcare providers.
The recalled product
- Product
- Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - 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 1909660037
- UDI 00840118115698
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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