BEUDAMED
    FDA Recall Open, Classified

    Tibial knee prosthesis

    Recall: Z-2774-2020 · Initiated July 16, 2020

    Recall

    Recall Number
    Z-2774-2020
    Event Number
    86068
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 16, 2020
    Posted
    August 8, 2020
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    Tibial knee prosthesis

    Reason

    Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

    Action

    On July 16th the firm send a letter to its consignees with the following instructions: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 2. Please provide a copy of the attached Physician Communication to the surgical staff. 3. If you have no product to return, please put an X in the appropriate location below. 4. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 5. Complete the remainder of the form, sign and send to [email protected]. Please Note even if you have no product to return, this form must be completed, signed and returned. 6. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact [email protected].

    Distribution

    Domestic Distribution: AL, LA ,MN, KY, AR, MN, GA, TX, WI, NJ, NC, CT, NY, OH, IA, IN, NC, MA, SC, NV, CT, WV, NY, OH, MN, MI, SC, TN, FL, AZ, PA and MO. International Distribution: Austria, Belgium, China, Canada, Switzerland, Colombia, Cyprus, Check Republic, Denmark, Spain, France, Great Britain, Greece, Hungary, India, Italy, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Russia, Sweden, Slovenia, Turkey and Ukraine.

    Quantity

    1,845 units