FDA Enforcement
Class II
Ongoing
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Recall: Z-1509-2026
·
Reported March 18, 2026
Enforcement
- Recall Number
- Z-1509-2026
- Event ID
- 98376
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Exactech, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 18, 2026
- Initiation Date
- February 3, 2026
- Classification Date
- March 9, 2026
- Address
- 2320 Nw 66th Ct, N/A, Gainesville, FL, 32653-1630, United States
Description
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Reason
Impactor handle may be missing cross-pin
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)
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
Quantity
120 units