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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 surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges.

FDA Recall Z-1086-2014 · Posted 2014-02-25

Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeLXH
Date Initiated2013-12-18
Date Terminated2014-08-25
Product Quantity21 units

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.

Firm Action

Stryker sent Urgent Medical Device Removal Notification letter and to their customers via email on 12/18/2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory, return affected product using enclosed pre-paid mailing label, complete Customer Response Form and fax to Regulatory Compliance at 855-632-9049 or mail it to [email protected]. For questions call 201-760-8287, 201-760-8298 or 201-760-8041.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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