Z-1573-2022Class II

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

Name: Z-1573-2022 HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Creator: Mizuho OSI
Published: 2021-07-29
License: https://open.fda.gov/license/

Mizuho Orthopedic Systems Inc / initiated 2021-07-29 / Open, Classified / root cause: manufacturing process

FDA source

Mizuho OSI began a recall of HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 on 2021-07-29. FDA classified it as Class II and gives the reason as "One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1573-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-29
Posted: 2022-08-24
Recalling firm: Mizuho Orthopedic Systems Inc
Product: HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 13 devices
Distribution: U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada
Product codes and lots: Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1573-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1573-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-24

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)