Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5...
FDA Recall #Z-0662-2016 — Class II — December 7, 2015
Product Description
Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.
Reason for Recall
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Recalling Firm
Innovasis, Inc — Salt Lake City, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
Distribution
Distributed in US -- CA; KS; OH; & TX.
Code Information
Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.