Z-0662-2016Class II

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...

Name: Z-0662-2016 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...
Creator: Innovasis, Inc
Published: 2015-12-07
License: https://open.fda.gov/license/

Innovasis, Inc / initiated 2015-12-07 / Terminated / root cause: labeling and UDI

FDA source

Innovasis, Inc began a recall of 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... on 2015-12-07. FDA classified it as Class II and gives the reason as "Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0662-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-07
Posted: 2016-01-19
Terminated: 2016-04-07
Recalling firm: Innovasis, Inc
Product: 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 code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Innovasis sent a Voluntary Product Recall letter, dated December 7, 2015 to customers regarding two lots of Excella II titanium rods which were packaged using each other's labels. Customers were asked to check their inventory and either remove the rod from the mislabeled package and request additional rods, or return the unopened packages immediately. The firm will replace all returned inventory upon receipt.
Quantity in commerce: 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
Distribution: Distributed in US -- CA; KS; OH; & TX.
Product codes and lots: Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0662-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0662-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-19

Product code NKB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)