FDA recall Z-0884-2021

Exactech, Inc. · Class II · device

Product

Equinoxe Humeral Stem, Primary, Press Fit, 11mm

Reason for recall

Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

Distribution

Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.

Key facts

Status
Ongoing
Initiation date
2020-11-09
Report date
2021-01-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0884-2021