Flower Orthoped: Recalls small left calcaneus plates (CPF 101) made with wrong titanium alloy. Risk of improper healing due to material error.
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Flower Orthopedics is recalling small left calcaneus plates (CPF 101) because they were made with the wrong titanium alloy. Using these plates could lead to improper bone healing since the material affects the device's strength and safety.
The plates were made with a titanium alloy instead of pure titanium. This material difference could weaken the plate, potentially causing improper bone healing or failure during use.
Patients who received the recalled calcaneus plate (CPF 101) for rearfoot fracture treatment. Those with the specific lot number 1909660028 are most at risk.
Check for the product name 'Calcaneus Plate, Extensile, Small, Left', catalog number CPF 101, and lot number 1909660028. The device is intended for internal bone fixation.
Verify the catalog number CPF 101 and lot number 1909660028 to confirm if your plate is recalled.
The recall indicates the material was incorrect, but the product is not safe for use as intended. Consult your doctor for guidance.
The recall does not specify a remedy, so contact Flower Orthopedics for further instructions.
Check for catalog number CPF 101 and lot number 1909660028 on the product label.
We’ve drafted a message you can send Flower Orthopedics to request your refund or repair — edit it as you like.
Subject: Recall Z-2782-2020 — Flower Orthopedics Flower Orthopedics Hello, I own a Flower Orthopedics that is covered by recall Z-2782-2020 from Flower Orthopedics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
