FDA-Device2014-03-05Class II
Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior
Stryker Spine
Hazard
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
Sold states
US Nationwide Distribution
Affected count
21 units
Manufactured in
2 Pearl Ct, Allendale, NJ, United States
Products
Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1086-2014Don't want to check this manually?
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