BEUDAMED
    FDA Recall Terminated

    Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.

    Recall: Z-2762-2019 · Initiated August 21, 2019

    Recall

    Recall Number
    Z-2762-2019
    Event Number
    83689
    Firm
    Zimmer GmbH Sulzerallee 8 Winterthur Switzerland
    FEI Number
    3005233524
    Product Code
    PKC
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    August 21, 2019
    Terminated
    July 20, 2020

    Description

    Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.

    Reason

    Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.

    Action

    Firm sent letter 8/21/2019 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, quarantine the product and notify the sales representative 3. Complete Certificate of Acknowledgement and send to [email protected]. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]

    Distribution

    Worldwide distribution - iUS Nationwide distribution including states of AL, CO, KS, NJ, NY, OH, and OK, and countries of Belgium, Czech Republic, France, Germany, Switzerland, and United Kingdom.

    Quantity

    19 unit worldwide