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Innovasis, Inc recalls 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 P
Recalled January 27, 2016 · FDA recall Z-0662-2016 · Innovasis
Hazard
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels. · FDA Class II
Units
17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
Sold at
Distributed in US -- CA; KS; OH; & TX.
Description
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Product
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.
Manufacturer(s)
Innovasis, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →