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.
Recall
- Recall Number
- Z-0662-2016
- Event Number
- 72878
- Firm
- Innovasis, Inc
- FEI Number
- 3004719693
- Product Code
- NKB
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- December 7, 2015
- Posted
- January 19, 2016
- Terminated
- April 7, 2016
- Address
- 614 E 3900 S, Salt Lake City, UT, 84107-1902
Description
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.
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
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.
Distributed in US -- CA; KS; OH; & TX.
17 units Labeled SR55100 Lot 1502 with SR55110 rods in package