Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Excella II Rod Cat. No.: SR 55100 5.5 x 100 Recalled by Innovasis, Inc Due to Innovasis recalled two lots of Excella II titanium...

Date: December 7, 2015
Company: Innovasis, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Innovasis, Inc directly.

Affected Products

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.

Quantity: 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package

Why Was This Recalled?

Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.

Where Was This Sold?

This product was distributed to 4 states: CA, KS, OH, TX

Affected (4 states)Not affected

About Innovasis, Inc

Innovasis, Inc has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report