BEUDAMED
    FDA Recall Terminated

    Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

    Recall: Z-1868-2014 · Initiated May 19, 2014

    Recall

    Recall Number
    Z-1868-2014
    Event Number
    68330
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    MBP
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    May 19, 2014
    Posted
    June 25, 2014
    Terminated
    September 5, 2014
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

    Reason

    This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix. Evo3C is contraindicated for treatment of vertebral compression and not indicated for use in the posterolateral spine.

    Action

    Integra sent an Urgent Voluntary Medical Device Recall dated May 19, 2014 to customers via mail (traceable courier service). The recall notification letter identified affected product, reason for recall and actions to be taken Customers were instructed to complete the "RECALL ACKNOWLEDGEMENT AND RETURN FORM". and return to: [email protected] or FAX to 1-609-275-9445. For questions contact Customer Service at 1-800-550-7155.

    Distribution

    US Nationwide Distribution

    Quantity

    61