Innovasis, Inc: Medical Device Recall in 2016 - (Recall #: Z-0662-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 7, 2015

Date Posted: January 27, 2016

Recall Number: Z-0662-2016

Event ID: 72878

Reason for Recall:

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

Status: Terminated

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

Code Information:

Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502

Distribution Pattern:

Distributed in US -- CA; KS; OH; & TX.

Voluntary or Mandated:

Voluntary: Firm initiated