Stryker Spine: Medical Device Recall in 2014 - (Recall #: Z-1086-2014)
See the recall detail below. You can also see other recalls from the same firm in 2014.
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.
Class II
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242
US Nationwide Distribution
Voluntary: Firm initiated