BEUDAMED
    FDA Recall Open, Classified

    Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

    Recall: Z-2105-2023 · Initiated June 13, 2023

    Recall

    Recall Number
    Z-2105-2023
    Event Number
    92460
    Firm
    Wright Medical Technology, Inc.
    FEI Number
    3010667733
    Product Code
    HSN
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 13, 2023
    Posted
    July 7, 2023
    Address
    1023 Cherry Rd, Memphis, TN, 38117-5423

    Description

    Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

    Reason

    The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

    Action

    The firm issued a Field Safety Correction Action (FSCA) Medical Devices Vigilance System form to the lead competent authority, ANSM-France, via email on 6/13/2023 for their review and approval for the recall to be carried out in their jurisdiction. The FSCA identified the affected product, a description of the issue, and advice on actions to be taken by the distributor and the user. The advice included to check the inventory to locate the product listed and remove and isolate/quarantine it to prevent accidental use. A business reply form was to be returned by email to confirm receipt of the notification and document product segregation. Upon receipt of the reply form, Stryker will contact the consignee for return of the product. If the devices have been distributed to other organizations, contact details are requested so that Stryker can inform the recipients appropriately. If the consignee is a distributor, they are responsible for notifying their affected customers. An undated recall letter accompanied the FSCA that will be issued once the lead competent authority approves it. The content of the letter was similar to the FSCA and contained a business reply form.

    Distribution

    There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.

    Quantity

    106 devices