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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Femoral Hook, Hana/ProFx Classic Femoral Hook Right see related information
Date Initiated by Firm July 29, 2021
Create Date August 24, 2022
Recall Status1 Open3, Classified
Recall Number Z-1573-2022
Recall Event ID 90603
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Code Information Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712
Recalling Firm/
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 2
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.