Device 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.
Z-2067-2014
Product summary
- Firm
- Innovasis, Inc
- Event
- Event 68781
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32
- Official record key
device-enforcement:Z-2067-2014
Official wording
Reason: Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Code information: E2S47525 Lot 1301 and E2S47535 Lot 1301
Distribution pattern: Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
Derived failure modes
-
Labeling or packaging
mislabeling