Mizuho OSI recalls HANA/PROFx Classic Femoral Hook Right Ref 6850-144 due to incorrect model numbering. Affected units have a specific batch code and require verification.
One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
Mizuho OSI is recalling a specific batch of HANA/PROFx Classic Femoral Hooks because they were incorrectly labeled with a different model number. This could lead to confusion during medical procedures if the wrong hook is used.
The hook was incorrectly etched with a "classic" model number instead of its actual model. This could cause medical staff to use the wrong device during procedures, potentially leading to incorrect surgical outcomes.
Medical professionals using the HANA/PROFx Classic Femoral Hook Right Ref 6850-144 with batch code MIZ210712 are most at risk. Patients using this device may face potential confusion in surgical procedures.
Check for the model number 6850-144 on the hook. Look for the batch code MIZ210712 on the device or its packaging. The UDI code starts with (01)00842430106842(10)MIZ210712.
Check the model number on the hook to ensure it is 6850-144.
Look for the batch code MIZ210712 on the device or its packaging.
The hook was incorrectly etched with a "classic" model number instead of its actual model number, which could cause confusion during medical procedures.
Check for the model number 6850-144 and batch code MIZ210712 on the hook or its packaging.
Verify the model number and batch code to ensure it is the correct one. If it matches the recalled batch, contact the manufacturer for further instructions.
We’ve drafted a message you can send Mizuho OSI to request your refund or repair — edit it as you like.
Subject: Recall Z-1573-2022 — Mizuho OSI Mizuho OSI Hello, I own a Mizuho OSI that is covered by recall Z-1573-2022 from Mizuho OSI. 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.
