Innovasis, Inc: Medical Device Recall in 2014 - (Recall #: Z-2067-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 7, 2014

Date Posted: July 23, 2014

Recall Number: Z-2067-2014

Event ID: 68781

Reason for Recall:

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

Status: Terminated

Product Quantity: 32

Code Information:

E2S47525 Lot 1301 and E2S47535 Lot 1301

Distribution Pattern:

Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.

Voluntary or Mandated:

Voluntary: Firm initiated