FDA DevicesClass II
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Cat...
Published: March 18, 2026Recall ID: Z-1509-2026Category: devicesCountry: US
Reason for Recall / Hazard
Impactor handle may be missing cross-pin
Product Description & Identification
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Affected Products
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Additional Source Details
| Field | Value |
|---|---|
| City | Gainesville |
| State | FL |
| Event id | 98376 |
| Address 1 | 2320 Nw 66th Ct |
| Address 2 | N/A |
| Code info | Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details) |
| Postal code | 32653-1630 |
| Report date | 20260318 |
| Product type | Devices |
| Product quantity | 120 units |
| Reason for recall | Impactor handle may be missing cross-pin |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260203 |
| Initial firm notification | Letter |
| Center classification date | 20260309 |
Overview
- Recalling FirmExactech, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS: 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