Recall Z-1509-2026 ยท HWA Impactor
Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
| Date | Mar 9, 2026 (initiated Feb 3, 2026) |
| Status | Open, Classified |
| Reason | Impactor handle may be missing cross-pin |
| Root cause | Under Investigation by firm |
| Action | On February 5, 2026, Exactech issued a Urgent Medical Device Recall Notification Expansion to affected consignees. Initial notification was issued on January 23, 2026. Exactech asked consignees to take the following actions: 1. IMMEDIATELY CEASE USE AND DISTRIBUTION. Stop using or distributing any Ergo Impactor Handle (321-09-05) from the affected lots. 2. CAREFULLY REVIEW THIS NOTIFICATION. Ensure all personnel understand the issue and required actions. 3. IDENTIFY, QUARANTINE AND RETURN 4. EXTEND THIS INFORMATION. Communicate this notice to all accounts that were shipped or may have been |
| Quantity | 120 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.