X Spine Systems Inc recalls Calix P PEEK Lumbar System, PLIF Trial

Recall date

May 17, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0125-2017

FDA classification

Class II

Brand / firm

X Spine Systems Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Calix P PEEK Lumbar System, PLIF Trial