BEUDAMED
    FDA Enforcement Class II Ongoing

    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    Recall: Z-1223-2021 · Reported March 17, 2021

    Enforcement

    Recall Number
    Z-1223-2021
    Event ID
    87251
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 17, 2021
    Initiation Date
    January 15, 2021
    Classification Date
    March 11, 2021
    Address
    375 River Park Cir, Marquette, MI, 49855-1781, United States

    Description

    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    Reason

    Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

    Code Info

    Batch Number: 333021 333022 338840 341489 343445 346886 351527 351528 351528 351528 351528 351528 351528 358459 358459 358459 358459 358459 358459 362405 363444 364766 364766 369197 369197 370268 377838 377838 379930 379930 379930 379930 379931 379931 385407

    Distribution

    US Nationwide distribution.