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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