X-Spine Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 35
- FDA recalls
- 9
At a glance
Market reach
- United States
- FDA recalls
What X-Spine Systems, Inc. makes
X-Spine Systems, Inc. makes spinal fixation and fusion devices, including pedicle screw systems, interspinous fusion systems, sacroiliac joint fusion systems, laminoplasty fixation systems, buttress plating systems, facet screw systems, and cervical interbody systems made from materials such as PEEK and porous titanium.
The company's devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. X-Spine Systems, Inc. is based in the United States.
Catalogue
Search and filter all 35 devicesFDA recalls
FDA recall records list 9 recalls initiated by X-Spine Systems, Inc., the earliest on 2009-03-24 and the most recent on 2016-05-17. By recorded status: 9 terminated. The reasons filed fall into these groups: labeling or instructions for use, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 17 May 2016 Z-0124-2017 Class II Terminated 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.
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- 17 May 2016 Z-0125-2017 Class II Terminated 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.
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- 17 May 2016 Z-0126-2017 Class II Terminated 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.
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- 17 May 2016 Z-0127-2017 Class II Terminated 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.
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- 17 May 2016 Z-0124-2017 Class II Terminated 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.
2015
- 7 Apr 2015 Z-1823-2015 Class II Terminated The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
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- 11 Mar 2015 Z-1512-2015 Class II Terminated 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.
- 7 Apr 2015 Z-1823-2015 Class II Terminated The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
2014
- 11 Jul 2014 Z-2136-2014 Class II Terminated Revision B of the tissue shields of the device was 7 mm longer than the previous design.
2011
- 15 Jul 2011 Z-0034-2012 Unclassified (pre-2012) Terminated The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque if the handles were turned at a very slow speed.
2009
- 24 Mar 2009 Z-1694-2009 Unclassified (pre-2012) Terminated A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that cradles the rod during fusion, and a screw that attached to the vertebra. The screw ball on the screw was manufactured out of tolerance (undersized).
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- 24 Mar 2009 Z-1694-2009 Unclassified (pre-2012) Terminated A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that cradles the rod during fusion, and a screw that attached to the vertebra. The screw ball on the screw was manufactured out of tolerance (undersized).
Frequently asked questions
How many devices does X-Spine Systems, Inc. have in the registry?
The registry currently lists 35 devices for X-Spine Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list X-Spine Systems, Inc.'s devices?
Among its 35 most recently registered devices, X-Spine Systems, Inc. has devices listed in FDA 510(k) (35 devices).
What risk classes do X-Spine Systems, Inc.'s devices fall under?
Among its 35 most recently registered devices, the classes recorded for X-Spine Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for X-Spine Systems, Inc.?
FDA recall records list 9 recalls initiated by X-Spine Systems, Inc., the most recent initiated on 2016-05-17. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from X-Spine Systems, Inc. in the registry?
The most recently registered devices listed for X-Spine Systems, Inc. include AXLE PEEK INTERSPINOUS FUSION SYSTEM, X-spine Pedicle Screw System, SILEX SACROILIAC JOINT FUSION SYSTEM and Certex Spinal Fixation System.