Z-0662-2016 Class II Terminated
FDA device recall Z-0662-2016 was initiated by Innovasis, Inc on December 7, 2015 and is designated Class II. Reason for recall: Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels. The recall status is terminated (terminated April 7, 2016). Affected quantity: 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2016
- Initiation Date
- December 7, 2015
- Termination Date
- April 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
Product 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.
Reason for Recall
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Distribution Pattern
Distributed in US -- CA; KS; OH; & TX.
Code Information
Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502