FDAFDA · Food and drugs·Recall number Z-2627-2014
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.
Published September 17, 2014 · Recall initiated: July 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Stryker Spine
- Distributor
- 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.
- Lot
- Catalog #IS3021ARI, Lot #'s 20774, 20798, 20805 and 21990
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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