Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage
Flower Orthopedics is recalling 25 calcaneus plates 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, a Class II recall without explicit reports of hospitalization or injury falls into the 'High' category (Score 3), representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Flower Orthopedics Corporation is recalling 25 units of the Calcaneus Plate, Extensile, Small, Right (Catalog Number CPF 201). 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 are identified by Lot Number 1909660034 and UDI 00840118115674. The products were distributed nationwide in the United States, including in the states of Arizona, Florida, and Ohio.
The recalled product
- Product
- Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - 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 1909660034
- UDI 00840118115674
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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