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Open, Classified

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

FDA Recall Z-1573-2022 · Posted None

Recalling FirmMizuho OSI
Recall StatusOpen, Classified
Product CodeLXH
Date Initiated2021-07-29
Product Quantity13 devices

Reason for Recall

One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

Firm 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.

Root Cause

Process control

Distribution Pattern

U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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