FDA-Device2022-08-31Class II
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Mizuho OSI
Hazard
One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
Sold states
U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada
Affected count
13 devices
Manufactured in
30031 Ahern Ave, Union City, CA, United States
Products
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1573-2022Don't want to check this manually?
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