FDA Device recall Z-2627-2014
Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand
- FDA Device
- Class II
- terminated
- Published 2014-09-17
On 2014-09-17 the FDA classified a Class II recall of Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand by Stryker Spine, citing stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2627-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-07 |
| Published | 2014-09-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Spine |
| Distribution | AL, AZ, CA, CO, FL, GA, IA, IN, KS, MA, MD, MI, MN, MO, MT, NY, OH, OK, OR, PA, TN, TX, UT, WI |
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.
Identifiers
| code_info | Catalog #IS3021ARI, Lot #'s 20774, 20798, 20805 and 21990 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2627-2014%22
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