Device 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.
Z-2627-2014
Product summary
- Firm
- Stryker Spine
- Event
- Event 68908
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57 units
- Official record key
device-enforcement:Z-2627-2014
Official wording
Reason: Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Code information: Catalog #IS3021ARI, Lot #'s 20774, 20798, 20805 and 21990
Distribution pattern: 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.
Derived failure modes
-
Unknown
Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.