Recall Z-1573-2022— Mizuho OSI

Name: FDA recall Z-1573-2022
Creator: U.S. Food and Drug Administration
Published: 2021-07-29

Class II · Ongoing

Class II FDA medical device recall by Mizuho OSI, initiated 2021-07-29. FDA's recall record names no specific 510(k) clearance for this event. Product: HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144. Reason: One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number..

Recalling firm: Mizuho OSI
Classification: Class II
Status: Ongoing
Initiated: 2021-07-29
Firm location: Union City, CA, United States

Product description

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.