Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of th...
FDA Recall #Z-1086-2014 — Class II — December 18, 2013
Product Description
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.
Reason for Recall
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
Recalling Firm
Stryker Spine — Allendale, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
21 units
Distribution
US Nationwide Distribution
Code Information
D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated