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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Aria Implant Inserter

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  Class 2 Device Recall Stryker Aria Implant Inserter see related information
Date Initiated by Firm July 07, 2014
Date Posted September 11, 2014
Recall Status1 Terminated 3 on May 08, 2017
Recall Number Z-2626-2014
Recall Event ID 68908
Product Classification Orthopedic manual surgical instrument - Product Code LXH
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.
Code Information Catalog #48758500, Lot #'s 107400, 10G906 and 110214; 
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Mr. Daniel Roberts
201-760-8298
Manufacturer Reason
for Recall		 Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
FDA Determined
Cause 2		 Device Design
Action Stryker Spine sent an "Urgent Medical Device Removal Notification/Customer Response" form dated July 7, 2014 to all their affected customers via Fedex. Customers were instructed to examine their inventory and hospital locations to identify the product. Fax a copy of the Customer Response Form to 855-632-9049 or email it to Spine-RegulatoryAction@Stryker.com. For questions regarding this recall call 201-760-8298.
Quantity in Commerce 64 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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