Recall Z-0662-2016
Innovasis, Inc · initiated December 7, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
Reason for recall
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-0662-2016
- Initiated
- December 7, 2015
- Posted by FDA
- January 19, 2016
- Terminated
- April 7, 2016
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
- Distribution
- Distributed in US -- CA; KS; OH; & TX.
- Recalling firm
- Innovasis, Inc, Salt Lake City, UT