HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 recallZ-1573-2022 · Mizuho OSI · initiated Jul 29, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mizuho OSI or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
FDA root cause category: Process control
What the company is doing
On or about 07/05/2022, Muzuho OSI Representative started visiting customers to inform them of a labeling error with the Femur Hook, Right 6850-918 which was incorrectly label with part number 6850-144. Mizuho Representatives were instructed to inform customers: -Over this summer, their facility should have received a Classic Femur Hook, Right 6850-144, either as part of your Hana Table purchase or as a replacement part. But, in error, may have received the other style of femur hook mislabeled with the part number 6850-144. -Hand deliver the Customer Notification Letter and Acknowledge Form. Mizuho Representative are further instructed to: -Inspect the customers' inventory and swap/replace all incorrectly labeled products with the correctly labeled product.
Recall details
- Recall number
- Z-1573-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 29, 2021
- Recalling firm
- Mizuho OSI
- Quantity
- 13 devices
- Product code
- LXH
- Distribution
- U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada
Product description
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Code information (models, lots, serial numbers)
Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Hana/ProFx Classic Femoral Hook Right 6850-144Mizuho Orthopedic Systems, Inc. · Orthopedic Manual Surgical Instrument1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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