FDAClass IISeptember 17, 2014

Specialty Aria Inserter recall

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…

Why was Specialty Aria Inserter recalled?

Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog #IS3021ARI, Lot #'s 20774, 20798, 20805 and 21990

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…
Recalling firm
Stryker Spine
Quantity
57 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.
Recall date
September 17, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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