BEUDAMED
    FDA Recall Terminated

    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.

    Recall: Z-2136-2014 · Initiated July 11, 2014

    Recall

    Recall Number
    Z-2136-2014
    Event Number
    68863
    Firm
    X Spine Systems Inc
    FEI Number
    3005031160
    Product Code
    FZX
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 11, 2014
    Posted
    August 1, 2014
    Terminated
    August 14, 2014
    Address
    452 Alexandersville Rd, Miamisburg, OH, 45342-3658

    Description

    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.

    Reason

    Revision B of the tissue shields of the device was 7 mm longer than the previous design.

    Action

    X-Spine systems contacted both customers via telephone and instructed to return the affected product back to X-Spine. All product has been recovered. The distributors have already returned the recalled product. No product was utilized in any surgical procedure. Immediate Action Taken: X-spine inventory was reviewed and two pieces of each size were recovered from finished inventory. The X-spine sales person returned the product. The distributor has returned the remaining product. The devices were recovered prior to use in any surgical procedure. For further questions please call (937) 847-8410

    Distribution

    US Distribution including the states of FL and MO.

    Quantity

    A total of 5-pieces of each part number distributed