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Innovasis, Inc recalls Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged i
Recalled July 23, 2014 · FDA recall Z-2067-2014 · Innovasis
Hazard
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number. · FDA Class II
Units
32
Sold at
Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
Description
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Product
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.
Manufacturer(s)
Innovasis, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →