FDA-Device2014-07-23Class II
Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
Innovasis, Inc
Hazard
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Sold states
Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
Affected count
32
Manufactured in
614 E 3900 S, N/A, Salt Lake City, UT, United States
Products
Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2067-2014Don't want to check this manually?
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