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.
Reported: January 27, 2016 Initiated: December 7, 2015 #Z-0662-2016
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.
Details
- Recalling Firm
- Innovasis, Inc
- Units Affected
- 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
- Distribution
- Distributed in US -- CA; KS; OH; & TX.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Innovasis, Inc. Units affected: 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package.
Why was this product recalled? ▼
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 27, 2016. Severity: Moderate. Recall number: Z-0662-2016.
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