Z-2627-2014Class II

Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is...

Name: Z-2627-2014 Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is...
Creator: Stryker Spine
Published: 2014-07-07
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2014-07-07 / Terminated / root cause: design

FDA source

Stryker Spine began a recall of 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... on 2014-07-07. FDA classified it as Class II and gives the reason as "Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2627-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-07
Posted: 2014-09-11
Terminated: 2017-05-08
Recalling firm: Howmedica Osteonics Corp
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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 57 units
Distribution: 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.
Product codes and lots: Catalog #IS3021ARI, Lot #'s 20774, 20798, 20805 and 21990

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2627-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2626-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-11
Z-2627-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-11

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)