Stryker Spine: Medical Device Recall in 2014 - (Recall #: Z-2627-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 7, 2014

Date Posted: September 17, 2014

Recall Number: Z-2627-2014

Event ID: 68908

Reason for Recall:

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

Status: Terminated

Product Quantity: 57 units

Code Information:

Catalog #IS3021ARI, Lot #'s 20774, 20798, 20805 and 21990

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.

Voluntary or Mandated:

Voluntary: Firm initiated