BEUDAMED
    FDA Recall Open, Classified

    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185

    Recall: Z-2104-2021 · Initiated May 12, 2021

    Recall

    Recall Number
    Z-2104-2021
    Event Number
    87942
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    May 12, 2021
    Address
    9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445

    Description

    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185

    Reason

    Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.

    Action

    On 5/12/2021, Encore Medical, LP (DJO) issued a "Urgent Field Safety Notice" via E-Mail. In addition to informing consignees about the recalled product the firm asked consignees to take the following actions by May 26, 2021: 1. This notice needs to be passed on to all those within your organization or to any outside organization or customer where the potentially affected product has been transferred. This recall should be carried out to the user level. 2.Review your stock for the affected products and lot numbers and quarantine the items until returned. 3. Contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. 5. Complete Field Safety Notice Consignee Reconciliation Form (Attachment 1) and return to DJO by May 26, 2021 (see return instructions in Attachment 1) 6. Report any adverse events related to this issue to Customer Service. Your actions above will demonstrate that you have received and understand this notification. Your assistance is appreciated and necessary to prevent the potential health hazards noted above. 7. If you have any questions, please contact Kiersten Soderman at 864-322-3801 or [email protected].

    Distribution

    US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None

    Quantity

    10 units