BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05

    Recall: Z-1509-2026 · Initiated February 3, 2026

    Recall

    Recall Number
    Z-1509-2026
    Event Number
    98376
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    HWA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 3, 2026
    Posted
    March 9, 2026
    Address
    2320 Nw 66th Ct, Gainesville, FL, 32653-1630

    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

    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 shipped affected units. 5. Response Form. A mandatory response form is attached. Please complete and return it to [email protected] within 5 business days.

    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