BEUDAMED
    FDA Enforcement Class II Terminated

    Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.

    Recall: Z-1392-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1392-2016
    Event ID
    73552
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    April 20, 2016
    Initiation Date
    February 18, 2016
    Classification Date
    April 14, 2016
    Termination Date
    November 8, 2016
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.

    Reason

    The label on the outer packaging does not match the product inside and intended use of the device.

    Code Info

    Lot # 9984134, Catalog ID 08.803.051, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve

    Distribution

    Distributed in the US: OH and ND

    Quantity

    6 units