Device 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.
Z-0662-2016
Product summary
- Firm
- Innovasis, Inc
- Event
- Event 72878
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
- Official record key
device-enforcement:Z-0662-2016
Official wording
Reason: Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Code information: Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
Distribution pattern: Distributed in US -- CA; KS; OH; & TX.
Derived failure modes
-
Unknown
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.