BEUDAMED
    FDA Recall Open, Classified

    RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044

    Recall: Z-3021-2020 · Initiated August 7, 2020

    Recall

    Recall Number
    Z-3021-2020
    Event Number
    86317
    FEI Number
    1644408
    Product Code
    PHX
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    August 7, 2020
    Address
    9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445

    Description

    RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044

    Reason

    Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.

    Action

    Letters were sent to the firm's Field/Sales Agents by email beginning on August 7, 2020. The letters included instructions to take the following actions by August 21, 2020: 1. Pass the notice on to all those within your organization or to any organization where the potentially affected product has been transferred, 2.Contact Customer Service at 1-800-456- 8696 to place a replacement order and receive a Return Materials Authorization (RMA) number, and to be provided with a shipping label to return the affected product. 3. Return all affected devices using the RMA number, and 4. Report any adverse events related to this issue to Customer Service. Customers with questions should contact Christine Chesnutt at 512-834-6207 or [email protected].

    Distribution

    Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA

    Quantity

    15 units