Reported Jan 27, 2016 · Terminated

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…

Innovasis, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Innovasis, Inc · 614 E 3900 S · Salt Lake City, UT · 84107-1902

Is this the product you have?

  • 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.
Lot codes and dates
  • Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
Amount recalled
17 units Labeled SR55100 Lot 1502 with SR55110 rods in package

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 7, 2016 · Data as of Sep 19, 5:20 PM UTC

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