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Terminated

Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter 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, ergonomically shaped anterior edges, and flat posterior edges. This device does not sustain or support life.

FDA Recall Z-2626-2014 · Posted 2014-09-11

Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeLXH
Date Initiated2014-07-07
Date Terminated2017-05-08
Product Quantity64 units

Reason for Recall

Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.

Firm Action

Stryker Spine sent an "Urgent Medical Device Removal Notification/Customer Response" form dated July 7, 2014 to all their affected customers via Fedex. Customers were instructed to examine their inventory and hospital locations to identify the product. Fax a copy of the Customer Response Form to 855-632-9049 or email it to [email protected]. For questions regarding this recall call 201-760-8298.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA including OR, AZ, TN, MA, MD, GA, FL, NY, IA, IN, TX, MI, PA, UT, CA, MN, MO, OH, KS, OK, MT, FL, AL, CO, TN, and WI and Internationally to Australia.

Official Source

View FDA Recall →

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

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