FDA-Device2016-10-26Class II
Calix P PEEK Lumbar System, PLIF Trial
X Spine Systems Inc
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.
Sold states
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.
Affected count
1504 units
Manufactured in
452 Alexandersville Rd, N/A, Miamisburg, OH, United States
Products
Calix P PEEK Lumbar System, PLIF Trial
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0125-2017Don't want to check this manually?
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