Exactech Class II Recall: Equinoxe Ergo Impactor Handle

The FDA has classified a recall for Exactech's Equinoxe Ergo Modular Impactor Handle as Class II (Z-1509-2026). The issue stems from the potential absence of a critical cross-pin in the impactor handle, which could compromise its functionality. The recall is ongoing and has a listed effective date of March 18, 2026.

Medical device manufacturers and distributors must ensure their inventory and distribution records are accurate regarding this specific model. While the document does not specify immediate actions for healthcare providers, they should be aware of this recall and verify the integrity of any Equinoxe Ergo Impactor Handles they possess. The recall impacts distribution across the US and several international markets, including Australia, France, Germany, and Japan.