Howmedica recalls Full Dose CE Simplex P Single Bone Cement due to missing Turkish language instructions. All content in instructions is accurate but Turkish translation is absent.
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
Howmedica is recalling Full Dose CE Simplex P Single Bone Cement because the Turkish language instructions for use are missing. This could affect patients who need the product in Turkish-speaking regions, though the rest of the instructions are accurate.
The instructions for use (IFU) are missing a Turkish translation, though all other content is accurate. This could cause confusion for users who need the instructions in Turkish, but the product itself is safe to use.
Patients using this bone cement in Turkish-speaking regions may be affected. Those who have the product but don't need Turkish instructions are unlikely to be at risk.
Check for the product name 'Full Dose CE Simplex P Single Bone Cement' with catalog number 6191-0-001. The product was sold from September 16, 2021, onward with expiration dates on or after that date.
Verify if the product includes Turkish language instructions for use (IFU).
Yes, all content in the instructions is accurate, though the Turkish translation is missing.
No, the product is safe to use, but you should check if Turkish instructions are included.
Check if the product includes Turkish language instructions for use. If not, contact Howmedica for guidance.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0736-2023 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0736-2023 from Howmedica. 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.
