FDA-Device2016-01-27Class II
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.
Innovasis, Inc
Hazard
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Sold states
Distributed in US -- CA; KS; OH; & TX.
Affected count
17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
Manufactured in
614 E 3900 S, N/A, Salt Lake City, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0662-2016Don't want to check this manually?
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