Data Foundry

Medical device recalls 2014

Stryker Aria Implant Inserter — Class II medical device recall Z-2626-2014

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 numberZ-2626-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStryker Spine, Allendale, NJ, United States
Recall initiated2014-07-07
Classified2014-09-11
Reported by FDA2014-09-17
Terminated2017-05-08
DistributedAL, 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 USAU
Quantity64 units
Lot numbers107400, 10G906, 110214
Model numbers48758500

Product

Stryker Aria Implant Inserter, REF 48758500, 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-2626-2014. 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.