Class 2 Device Recall Femoral Hook, Hana/ProFx Classic Femoral Hook Right

• Date Initiated by Firm: July 29, 2021
• Create Date: August 24, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1573-2022
• Recall Event ID: 90603
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
• Code Information: Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712
• Recalling Firm/ Manufacturer: Mizuho OSI; 30031 Ahern Ave; Union City CA 94587-1234
• For Additional Information Contact: Krina Shah; 800-777-4674 Ext. 128
• Manufacturer Reason for Recall: One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.