Specialty Aria Inserter — Class II medical device recall Z-2627-2014
Terminated recall by Stryker Spine, reported 2014-09-17, distributed in AL, AZ, CA, CO, FL, GA, IA, IN…. Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of pro
| Recall number | Z-2627-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2014-07-07 |
| Classified | 2014-09-11 |
| Reported by FDA | 2014-09-17 |
| Terminated | 2017-05-08 |
| Distributed | AL, AZ, CA, CO, FL, GA, IA, IN, KS, MA, MD, MI, MN, MO, MT, NY, OH, OK, OR, PA, TN, TX, UT, WI |
| Countries outside the US | AU |
| Quantity | 57 units |
| Lot numbers | 20774, 20798, 20805, 21990 |
| Model numbers | IS3021ARI |
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 for recall
Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2627-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.