BEUDAMED
    FDA Recall Terminated

    Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068

    Recall: Z-0104-2022 · Initiated September 8, 2021

    Recall

    Recall Number
    Z-0104-2022
    Event Number
    88630
    FEI Number
    3008599177
    Product Code
    OVE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 8, 2021
    Terminated
    May 17, 2024
    Address
    K2M Inc 600 Hope Pkwy SE, Leesburg, VA, 20175-4428

    Description

    Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068

    Reason

    Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.

    Action

    On September 8, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Actions Needed: 1. Immediately check your internal inventory to locate the product listed in the letter and remove them from their point of use. 2. Use the included Business Reply Form to reconcile any affected product. Complete the Business Reply Form even if there is no affected product identified. 3. Return the enclosed Business Reply Form by email to [email protected] to confirm receipt of this notification/document product segregation. Your account s Stryker Spine Sales Representative will arrange for retrieval and removal of any instruments associated with this recall. 4. In the interim, until units can be removed from your facility by Stryker, there are no additional actions that users can and should take once the product has been segregated and removed from point of use. - If you desire additional training associated with these instructions, please contact our Regulatory Compliance team by calling 201.749.8090 or by email at [email protected], or contact your local Sales representative. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. 7. Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by using Stryker s online reporting site: https://www.stryker.com/productexperience. Additionally, adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program: https://www.accessdata.fda.gov/scripts/medwatch/index

    Distribution

    Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.

    Quantity

    23