BEUDAMED
    FDA Recall Open, Classified

    iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm

    Recall: Z-0227-2026 · Initiated September 11, 2025

    Recall

    Recall Number
    Z-0227-2026
    Event Number
    97676
    Firm
    Theken Companies LLC
    FEI Number
    3002498892
    Product Code
    MEH
    Status
    Open, Classified
    Root Cause
    Package design/selection
    Initiated
    September 11, 2025
    Posted
    October 21, 2025
    Address
    1800 Triplett Blvd, Akron, OH, 44306-3311

    Description

    iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm

    Reason

    Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

    Action

    NextStep Arthropedix contacted their distributors via phone on September 11-12, 2025, to notify them of the situation. The distributors were instructed to quarantine and return all Bipolar Head implants. A formal recall letter with instructions for returning the inventory to NextStep Arthropedix was sent to customers on September 19, 2025.

    Distribution

    US Nationwide distribution in the states of NJ, PA, and TX.

    Quantity

    409