Mizuho OSI HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Brand
Mizuho OSI
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712
Mizuho OSI is recalling HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 due to One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026