Recall Z-0662-2016 ยท NKB Thoracolumbosacral Pedicle Screw System
Innovasis, Inc
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.
| Date | Jan 19, 2016 (initiated Dec 7, 2015) |
| Status | Terminated |
| Reason | Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels. |
| Root cause | Labeling mix-ups |
| Action | Innovasis sent a Voluntary Product Recall letter, dated December 7, 2015 to customers regarding two lots of Excella II titanium rods which were packaged using each other's labels. Customers were asked to check their inventory and either remove the rod from the mislabeled package and request additional rods, or return the unopened packages immediately. The firm will replace all returned inventory upon receipt. |
| Quantity | 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package |
| Distribution | Distributed in US -- CA; KS; OH; & TX. |
| FDA record | Open on fda.gov |