FDA recall Z-1509-2026

Exactech, Inc. · Class II · device

Product

Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05

Reason for recall

Impactor handle may be missing cross-pin

Distribution

US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia

Key facts

Status
Ongoing
Initiation date
2026-02-03
Report date
2026-03-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1509-2026