BEUDAMED
    FDA Enforcement Class II Terminated

    Calix P PEEK Lumbar System, PLIF Trial

    Recall: Z-0125-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0125-2017
    Event ID
    74397
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    X Spine Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2016
    Initiation Date
    May 17, 2016
    Classification Date
    October 18, 2016
    Termination Date
    April 4, 2019
    Address
    452 Alexandersville Rd, N/A, Miamisburg, OH, 45342-3658, United States

    Description

    Calix P PEEK Lumbar System, PLIF Trial

    Reason

    The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.

    Code Info

    Size, 22mm x 10mm x 6mm, Part #:, X034-0970, Lot #:, 015857-6-1, 021425, 025070, 28221, 31896, 656802; Size, 22mm x 10mm x 7mm, Part #:, X034-0971, Lot #:, 015857-6-1, 021425, 025070, 28221, 31896, 656802; Size, 22mm x 10mm x 8mm, Part #:, X034-0972, Lot #:, 015857-7-1, 021426, 025071, 28224, 656803; Size, 22mm x 10mm x 9mm, Part #:, X034-0973, Lot #:, 015857-8-1, 021427, 025072, 28225, 28225R, 656804; Size, 22mm x 10mm x 10mm , Part #:, X034-0974, Lot #:, 015857-9-1, 021428, 025073, 28226, 656805; Size, 22mm x 10mm x 11mm, Part #:, X034-0975, Lot #:, 015857-10-1, 021429, 025074, 28227, 656806; Size, 22mm x 10mm x 12mm, Part #:, X034-0976, Lot #:, 015857-11-1, 021430, 025075, 28228, 656807; Size, 22mm x 10mm x 13mm, Part #:, X034-0977, Lot #:, 015857-12-1, 021432, 025076, 28229, 656808; Size, 22mm x 10mm x 14mm, Part #:, X034-0978, Lot #:, 015857-13-1,021433, 025077,125077, 28230, 656809; Size, 22mm x 10mm x 15mm, Part #:, X034-0979, Lot #:, 656810, 015857-13, 21434, 25078, 28231; Size, 22mm x 10mm x 16mm, Part #:, X034-0980, Lot #:, 015857-15-1, 015857-16-1, 021435, 021436, 025079, 28232, 656811; Size, 26mm x 10mm x 6mm, Part #:, X034-1050, Lot #:, 015857-15-1, 015857-16-1, 021435, 021436, 025079, 28232, 656811; Size, 26mm x 10mm x 8mm, Part #:, X034-1052, Lot #:, 015857-19-1, 021439, 025081, 10346, 26234, 28234, 656813, 656813R; Size, 26mm x 10mm x 9mm, Part #:, X034-1053, Lot #:, 10121, 11947; Size, 26mm x 10mm x 10mm, Part #:, X034-1054, Lot #:, 015857-20-1, 021440, 025082, 28235, 656814; Size, 26mm x 10mm x 11mm, Part #:, X034-1055, Lot #:, 10124, 11948; Size, 26mm x 10mm x 12mm, Part #:, X034-1056, Lot #:, 015857-21-1, 021441, 025083, 28236, 656815; Size, 26mm x 10mm x 13mm, Part #:, X034-1057, Lot #:, 10125, 11949 & Size, 26mm x 10mm x 14mm, Part #:, X034-1058, Lot #:, 021443, 015857-22-1, 015857-23-1, 021442, 021443, 025084, 28237, 656816.

    Distribution

    Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV. Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.

    Quantity

    1504 units