BEUDAMED
    FDA Recall Terminated

    Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962

    Recall: Z-2100-2021 · Initiated May 18, 2021

    Recall

    Recall Number
    Z-2100-2021
    Event Number
    88217
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    NDN
    Status
    Terminated
    Root Cause
    Storage
    Initiated
    May 18, 2021
    Terminated
    April 15, 2022
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962

    Reason

    The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.

    Action

    Urgent Medical Device Recall notification letters dated 5/14/21 were sent to customers. Actions needed NOTE: due to the potential hazards/risks associated with use of product associated with these shipments, please urgently quarantine the in-scope product. 1. Immediately review the Product Recall Notification. Please forward this information to all appropriate personnel within your organization. Maintain awareness of this communication internally until all required actions have been completed within your facility. 2. Immediately check your internal inventory to locate the affected products. Quarantine and discontinue use of any affected Cortoss Bone Augmentation Material. Your local Stryker Representative is available to assist with removal of this product. 3. Complete the enclosed business reply form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please return the BRF, even if you dont have any affected product on hand, via email to [email protected]. 4. Upon receipt of the completed BRF, replacement(s) will be shipped to your facility. 5. If you have further distributed this product to other organizations, please provide contact details on the BRF so that Stryker can inform the recipients appropriately. If you have any questions or concerns, please contact Regulatory Compliance at 201-749-8090.

    Distribution

    US Nationwide Distribution

    Quantity

    559 total