CLASS II Device recall · Reported 17 Sep 2014 · FDA Enforcement Report

Specialty Aria Inserter recalled by Stryker Spine

Stryker Spine is recalling Specialty Aria Inserter, distributed in 23 states. The recall was initiated on 7 Jul 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog #IS3021ARI, Lot #'s 20774, 20798, 20805 and 21990

Quantity recalled57 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2627-2014
FDA event ID: 68908
Recalling firm: Stryker Spine, Allendale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 7 Jul 2014
FDA classified: 11 Sep 2014
Reported: 17 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

7 Jul 2014	Recall initiated by company
11 Sep 2014	Classified by FDA	+66 days
17 Sep 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Alabama Arizona California Colorado Florida Georgia Iowa Indiana Kansas Massachusetts Maryland Michigan Minnesota Missouri Montana New York Ohio Oklahoma Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 68908

This product is part of a recall event; the main page for the event is Stryker Aria Implant Inserter recalled by Stryker Spine.

Reported	Class	Recall	Company	Reason	Where
17 Sep 2014	CLASS II	Stryker Aria Implant Inserter recalled by Stryker Spine	Stryker Spine	Device Malfunction	23 states

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