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X Spine Systems Inc recalls Calix P PEEK Lumbar System, PLIF Trial
Recalled October 26, 2016 · FDA recall Z-0125-2017 · X Spine Systems
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. · FDA Class II
Units
1504 units
Sold at
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.
Description
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.
Product
Calix P PEEK Lumbar System, PLIF Trial
Manufacturer(s)
X Spine Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →