HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
This recall is currently active, issued July 29, 2021. It was issued by Mizuho Osi.
- Company
- Mizuho Osi
- Recall Initiated
- July 29, 2021
- Recall Number
- Z-1573-2022
- Quantity
- 13 devices
- Firm Location
- Union City, CA
- Official Source
- View on FDA website ↗
Reason for Recall
One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
Distribution
U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada
Lot / Code Info
Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712
Root Cause
Process control
Action Taken
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.