Flower Orthoped: Recalls left calcaneus plates (CPF 103) 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 left calcaneus plates (CPF 103) because they were made with an incorrect titanium alloy. This could lead to improper bone healing or complications during recovery.
The plates were manufactured with a titanium alloy instead of pure titanium. This material difference could cause improper bone healing or complications during recovery, though serious injury is unlikely.
Patients who have received the left calcaneus plate (CPF 103) for foot fracture treatment are affected. Those with the specific lot number 1909660033 are at highest risk.
Check for the product name 'Calcaneus Plate, Extensile, Large, Left' with catalog number CPF 103. Look for lot number 1909660033 or unique device identifier 00840118115667.
Verify the catalog number CPF 103 and lot number 1909660033 on the plate.
The contract manufacturer used the incorrect titanium alloy instead of pure titanium, which could affect bone healing.
The recall indicates a risk of improper healing, but serious injury is unlikely with proper use.
Check for catalog number CPF 103 and lot number 1909660033 on the plate.
We’ve drafted a message you can send Flower Orthopedics to request your refund or repair — edit it as you like.
Subject: Recall Z-2784-2020 — Flower Orthopedics Flower Orthopedics Hello, I own a Flower Orthopedics that is covered by recall Z-2784-2020 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.
