Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for I
FDA device recall Z-2627-2014 · posted 2014-09-11 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 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.
- Date initiated
- 2014-07-07
- Date posted
- 2014-09-11
- Date terminated
- 2017-05-08
- Location
- Allendale, NJ
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