BEUDAMED
    FDA Enforcement Class II Terminated

    smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.

    Recall: Z-0092-2018 · Reported November 22, 2017

    Enforcement

    Recall Number
    Z-0092-2018
    Event ID
    78140
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 22, 2017
    Initiation Date
    September 14, 2017
    Classification Date
    November 16, 2017
    Termination Date
    August 21, 2020
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.

    Reason

    The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

    Code Info

    Lot Number 14GSM0440A

    Distribution

    US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand

    Quantity

    10 units