BEUDAMED
    FDA Recall Open, Classified

    Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)

    Recall: Z-2562-2025 · Initiated August 15, 2025

    Recall

    Recall Number
    Z-2562-2025
    Event Number
    97459
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    PHX
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    August 15, 2025
    Posted
    September 12, 2025
    Address
    2320 Nw 66th Ct, Gainesville, FL, 32653-1630

    Description

    Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)

    Reason

    Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

    Action

    On August 15, 2025, Exactech, Inc. initiated a "Urgent Voluntary Medical Device Recall". Exactech asked consignees to take the following actions: 1. Healthcare providers who have treated patients using the Exactech Equinoxe Humeral Liners subject to this recall should continue to follow those patients pursuant to the healthcare provider s standard of care. 2. Do Not Use / Quarantine any of these products in your inventory. 3. Segregate and return unused units via prepaid packaging to Exactech. 4. Complete the Recall Confirmation Form confirming product return or on-hand inventory. 5. Transmission of this Recall Notice: This notice must be passed on to all who need to be aware within your organization and any locations the affected products has been transferred to. This recall has been reported to the U.S. FDA and will be reported to other regulatory authorities as required.

    Distribution

    Worldwide - US Nationwide distribution in the states of 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 and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai.

    Quantity

    11,542 units