FDA Medical Device Recalls (openFDA)
Mizuho OSI: HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
- Recall number
- Z-1573-2022
- Recalling firm
- Mizuho OSI
- Product
- HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
- Status
- Open, Classified
- Initiated
- 2021-07-29
- Posted
- not on file
- Terminated
- not on file
- Reason
- One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
- 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
- 13 devices
- Distribution
- U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada
- Lot, serial or model codes
- Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 2921578
- Firm city
- Union City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28