FDA recall Z-1573-2022

Mizuho OSI · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2021-07-29
Report date
2022-08-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Union City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1573-2022