Howmedica recalls Tobra Full Dose antibiotic cement due to missing Turkish language instructions. All products with lot numbers from October 28, 2021 onward are affected. Contact for remedy details.
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 Tobra Full Dose antibiotic cement products because the Turkish language instructions for use are missing. This could cause confusion for patients using the product in Turkish-speaking regions, but the product itself remains safe and accurate.
The instructions for use (IFU) are missing Turkish translation, though the content is accurate. This could lead to confusion about proper use for patients who don't understand English. However, the product itself is safe and accurate.
Patients using Tobra Full Dose cement in Turkish-speaking regions may be affected. Those with the product from October 28, 2021 onward are most at risk.
Check for the product name 'Tobra Full Dose CE Antibiotic Simplex P' with catalog number 6197-1-001. Products manufactured under revision AB with expiration dates from October 28, 2021 onward are affected.
Look for catalog number 6197-1-001 and expiration date from October 28, 2021 onward.
Yes, the product is safe and accurate, but the Turkish instructions are missing.
No, the product remains safe, but you should check for the missing Turkish instructions.
The recall record does not specify a remedy, so contact Howmedica for further instructions.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0737-2023 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0737-2023 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.
