Recall Z-2067-2014— Innovasis, Inc

Name: FDA recall Z-2067-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-07

Class II · Terminated

Class II FDA medical device recall by Innovasis, Inc, initiated 2014-07-07, terminated 2014-08-11. It names 2 FDA 510(k) clearances: K140238, K102248. Product: Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.. Reason: Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number..

Recalling firm: Innovasis, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-07-07
Terminated: 2014-08-11
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 Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.

Reason for recall

Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.

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