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X Spine Systems Recalls
7 recalls on record · August 13, 2014 to October 26, 2016 · Medical Devices
Recalls by year
14
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 26, 2016Medical DevicesFDA
X Spine Systems Inc recalls Calix T PEEK Lumbar System, TLIF Trial
Hazard: 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.
October 26, 2016Medical DevicesFDA
X Spine Systems Inc recalls Calix T PEEK Lumbar System, TLIF Rasp
Hazard: 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.
October 26, 2016Medical DevicesFDA
X Spine Systems Inc recalls Calix P PEEK Lumbar System, PLIF Trial
Hazard: 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.
October 26, 2016Medical DevicesFDA
X Spine Systems Inc recalls Calix P PEEK Lumbar System, PLIF Rasp
Hazard: 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.
July 1, 2015Medical DevicesFDA
X Spine Systems Inc recalls Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisbur
Hazard: The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
April 29, 2015Medical DevicesFDA
X Spine Systems Inc recalls Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, p
Hazard: One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
August 13, 2014Medical DevicesFDA
X Spine Systems Inc recalls Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tis
Hazard: Revision B of the tissue shields of the device was 7 mm longer than the previous design.