Device Recall Calix T PEEK Lumbar System

  • Model / Serial
    Size, 28mm x 10mm x 6mm, Part #:, X034-0360, Lot #:, 23515, 23516, 24295, 24836, 24836s1, 24836S2, 657001, 760913 & Size, 28mm x 10mm x 10mm, Part #:, X034-0364, Lot #:, 23517, 23518, 24296, 24837, 657002, 760914.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product Description
    Calix T PEEK Lumbar System, TLIF Rasp
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Size, 28mm x 10mm x 6mm, Part #:, X034-0340, Lot #:, 118501, 23502, 23503, 24284, 24291, 24825, 24825s1, 24825S2, 760902; Size, 28mm x 10mm x 7mm, Part #:, X034-0341, Lot #:, 118502, 23504, 24285, 24826, 24826S1, 24826S2, 760903; Size, 28mm x 10mm x 8mm, Part #:, X034-0342, Lot #:, 118503, 23505, 24286, 24827, 24827S1, 24827S2, 760904; Size, 28mm x 10mm x 9mm, Part #:, X034-0343, Lot #:, 118504, 23506, 24287, 24828, 24828S1, 24828S2, 760905; Size, 28mm x 10mm x 10mm, Part #:, X034-0344, Lot #:, 118505, 23507, 24288, 24829, 24829S1, 24829S2, 760906; Size, 28mm x 10mm x 11mm, Part #:, X034-0345, Lot #:, 118506, 23508, 24289, 24830, 24830S1, 24830S2, 760907; Size, 28mm x 10mm x 12mm, Part #:, X034-0346, Lot #:, 118507, 23509, 24290, 24831, 24831S1, 24831s2, 760908; Size, 28mm x 10mm x 13mm, Part #:, X034-0347, Lot #:, 118508, 23510, 24291, 24832, 24832s1, 24832S2, 760909; Size, 28mm x 10mm x 14mm, Part #:, X034-0348, Lot #:, 118509, 23511, 24292, 24833, 760910; Size, 28mm x 10mm x 15mm, Part #:, X034-0349, Lot #:, 118510, 23512, 24293, 24293-R, 24834, 760911 & Size, 28mm x 10mm x 16mm, Part #:, X034-0350, Lot #:, 118511, 23513, 23514, 24294, 24835, 24835S1, 24835S2, 32513, 760912.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product Description
    Calix T PEEK Lumbar System, TLIF Trial
  • Manufacturer