Recall Z-1509-2026— Exactech, Inc.
Class II · Ongoing
Class II FDA medical device recall by Exactech, Inc., initiated 2026-02-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05. Reason: Impactor handle may be missing cross-pin.
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-03
- Firm location
- Gainesville, FL, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.