BEUDAMED
    FDA Recall Open, Classified

    Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252

    Recall: Z-1769-2026 · Initiated March 5, 2026

    Recall

    Recall Number
    Z-1769-2026
    Event Number
    98512
    Firm
    Tornier, Inc
    FEI Number
    3000718467
    Product Code
    KWS
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    March 5, 2026
    Posted
    April 3, 2026
    Address
    10801 Nesbitt Ave S, Bloomington, MN, 55437-3109

    Description

    Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252

    Reason

    Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

    Action

    On March 5, 2026, the firm notified affected customers of the product issue. Customers were instructed to locate affected product in their inventory. Relevant personnel should be informed that the affected product must not be used with Tornier HRS Max products, as they are incompatible. Product return is not necessary, but customers may contact the recalling firm to arrange for return if the product issue impacts their needs.

    Distribution

    US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI.

    Quantity

    233