Recall Z-0662-2016— Innovasis, Inc

Name: FDA recall Z-0662-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-07

Class II · Terminated

Class II FDA medical device recall by Innovasis, Inc, initiated 2015-12-07, terminated 2016-04-07. It names 2 FDA 510(k) clearances: K140238, K102248. 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.. Reason: Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels..

Recalling firm: Innovasis, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-12-07
Terminated: 2016-04-07
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

2 on FDA's record

K140238 — EXCELLA III-D SPINAL DEFORMITY SYSTEMInnovasis, Inc.·cleared 2014-05-07
K102248 — EXCELLA II SPINAL SYSTEM MODEL EC2-00Innovasis, Inc.·cleared 2010-10-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.