Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog... recall (Exactech, Inc.)
Medical deviceClass IIOngoing
Summary: Exactech, Inc. is recalling Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05. Reason: Impactor handle may be missing cross-pin.
What is being recalled
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Why
Impactor handle may be missing cross-pin
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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 (states named: California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Wisconsin)
How to tell if yours is affected
Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details)
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1509-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 3, 2026 |
| Reported | March 18, 2026 |
| Company | Exactech, Inc. |
| Company location | Gainesville, FL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 120 units |
More recalls from Exactech, Inc. · all medical device recalls · recalls from February 2026