Mizuho OSI HANA/PROFx Classic Femoral Hook Recall: Incorrect Model Etching
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.
Lower-risk recall
One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/62126-mizuho-osi-hana-profx-classic-femoral-hook-recall-incorrect-model.
Source Summary by GovInfoNow · govinfonow.com/recall/62126-mizuho-osi-hana-profx-classic-femoral-hook-recall-incorrect-model · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1573-2022
Cite this page
“Mizuho OSI HANA/PROFx Classic Femoral Hook Recall: Incorrect Model Etching.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62126-mizuho-osi-hana-profx-classic-femoral-hook-recall-incorrect-model. Based on FDA recall #Z-1573-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1573-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Mizuho OSI- Product
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144- Category
Medical device
What to do — step by step
Verify Model Number
Check the model number on the hook to ensure it is 6850-144.
Check Batch Code
Look for the batch code MIZ210712 on the device or its packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 9 states.
FDA distribution: “U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Michigan, Nebraska, New Jersey, Tennessee, Utah, Washington.
Recall timeline
FDA published this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the recalled hook?
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.
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Where this comes from
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.
- Official source: FDA Recall #Z-1573-2022 (July 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1573-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.