Recall Z-2067-2014 ยท NKB Thoracolumbosacral Pedicle Screw System
Innovasis, Inc
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.
| Date | Jul 16, 2014 (initiated Jul 7, 2014) |
| Status | Terminated |
| Reason | Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number. |
| Root cause | Process control |
| Action | Distributors were notified by e-mail on 7/7/14, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis. Distributors have been instructed to return all inventory in stock. |
| Quantity | 32 |
| Distribution | Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan. |
| FDA record | Open on fda.gov |