BEUDAMED
    FDA Recall Terminated

    Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein) "Catalog numbers: 300-50, 300-55 OP-1 Putty is authorized by Federal law for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.

    Recall: Z-1727-2011 · Initiated October 25, 2010

    Recall

    Recall Number
    Z-1727-2011
    Event Number
    56962
    Firm
    Stryker Biotech
    FEI Number
    1000513212
    Product Code
    OJZ
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    October 25, 2010
    Posted
    March 18, 2011
    Terminated
    March 20, 2012
    Address
    35 South St, Hopkinton, MA, 01748-2218

    Description

    Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein) "Catalog numbers: 300-50, 300-55 OP-1 Putty is authorized by Federal law for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.

    Reason

    A change to the Preparation for Use section was identified where 2.5cc was replaced with 2cc-3cc volume and was not approved

    Action

    The firm, Stryker Biotech, sent a "Medical Device Correction" letter on October 15, 2010 via return receipt letter to all customers. The letter contains labeling with the approved Preparation for Use Section of 2.5 cc volume and included the revised copy of the Package Insert. Additionally, the letter described the product, problem and actions to be taken. The customers were instructed to follow the new instructions provided and to keep the new instructions in mind when using the OP-1 Putty. If you have any questions concerning this communication, please contact 508-416-5326 or Stryker Biotech's Pharmacovigilance department at [email protected].

    Distribution

    Nationwide distribution.

    Quantity

    2861 units