BEUDAMED
    FDA Recall Terminated

    Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench

    Recall: Z-1986-2019 · Initiated July 1, 2019

    Recall

    Recall Number
    Z-1986-2019
    Event Number
    83218
    Firm
    Clariance Inc
    FEI Number
    3009962553
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    July 1, 2019
    Terminated
    July 9, 2020
    Address
    4809 N Ravenswood Ave, Unit 119, Chicago, IL, 60640-4417

    Description

    Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench

    Reason

    Potential for the polyaxial screw to become disassembled during implant.

    Action

    Clariance, Inc. notified customers on about 07/01/2019 via "MEDICAL DEVICE FIELD SAFETY NOTICE - SN20190603". Customers were informed that when using the 18710024 Screwdriver, the user should ensure that the tip of the screwdriver is properly engaged into the receiving Torx bore of the Erisma-LP polyaxial screw. After proper engagement, the user is able to fully connect the screwdriver on the screw head. Disassembly of the polyaxial screw can occur when the 18710024 Screwdriver is not fully inserted and threaded into the screw head. Additionally when using the 18720000T20 Wrench or 01720001 T20 Snap Fit Tightening Wrench, the user should ensure that the tip of the T20 Wrench or the T20 Snap Fit Tightening Wrench is properly engaged into the receiving Torx bore of the Erisma-LP polyaxial screw. After proper engagement the user is able to adjust the insertion depth of the polyaxial screw. Customers were instructed to read the Field Safety Notice carefully, review the revised Surgical Techniques Guide provided as Attachment A that include in Section 2, Insertion of Pedicle Screws, enhanced instructions to help ensure that the user properly uses the 18710024 Screwdriver, the 18720000T20 Wrench, or the 01720001 T20 Snap Fit Tightening Wrench with the Erisma-LP polyaxial screws, in order to help reduce the possibility of disassembly. They were also instructed to replace the existing Surgical Techniques Guide(s) within your files with the revised Surgical Techniques Guide and to complete and return the response card, Attachment B. Questions can be directed to Clariance via telephone 773-868-7041, or your local sales representative.

    Distribution

    Nationwide distribution to CA, IL, IN, NY, OH, TX.

    Quantity

    4,090 units distributed in the US