BEUDAMED
    FDA Recall 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 · Initiated February 18, 2016

    Recall

    Recall Number
    Z-1392-2016
    Event Number
    73552
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 18, 2016
    Terminated
    November 8, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    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.

    Action

    DePuy Synthes sent an Urgent Notice letter dated February 18, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory, immediately remove the affected lots from their stock and complete the attached Verification Section. For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant

    Distribution

    Distributed in the US: OH and ND

    Quantity

    6 units