BEUDAMED
    FDA Recall Open, Classified

    smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60MM 71335560 Orthopedic implant component.

    Recall: Z-2333-2020 · Initiated April 22, 2020

    Recall

    Recall Number
    Z-2333-2020
    Event Number
    85637
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    MBL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 22, 2020
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60MM 71335560 Orthopedic implant component.

    Reason

    A manufacturing error resulted in out of specification R3 Acetabular Shells

    Action

    The firm notified its consignees by letter (delivered by Fed Ex) and email beginning on 04/22/2020. Consignees are asked to inspect inventory, locate and quarantine affected devices. Affected product will be returned to Smith & Nephew. Questions or concerns regarding this recall may be directed to: [email protected].

    Distribution

    Worldwide

    Quantity

    6468 devices