Recall Z-2626-2014 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Spine
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 diff
| Date | Sep 11, 2014 (initiated Jul 7, 2014) |
| Status | Terminated |
| Reason | Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.