Recall Z-2627-2014— Stryker Spine

Class II FDA medical device recall by Stryker Spine, initiated 2014-07-07, terminated 2017-05-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, 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.. Reason: Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing..

Recalling firm

Stryker Spine

Classification

Class II

Status

Terminated

Initiated

2014-07-07

Terminated

2017-05-08

Firm location

Allendale, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.