PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 5, 2014 Initiated: December 18, 2013 #Z-1086-2014

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.

Details

Recalling Firm
Stryker Spine
Units Affected
21 units
Distribution
US Nationwide Distribution
Location
Allendale, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Stryker Spine. Units affected: 21 units.
Why was this product recalled? ▼
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-1086-2014.

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