Device product
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Z-1509-2026
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 98376
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 120 units
- Official record key
device-enforcement:Z-1509-2026
Official wording
Reason: Impactor handle may be missing cross-pin
Code information: Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details)
Distribution pattern: 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
Derived failure modes
-
Unknown
Impactor handle may be missing cross-pin