Home / Recalls / Innovasis, Inc / Z-2067-2014

Z-2067-2014 Class II Terminated

Recalled by Innovasis, Inc — Salt Lake City, UT

Recall Details

Product Type
Devices
Report Date
July 23, 2014
Initiation Date
July 7, 2014
Termination Date
August 11, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32

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.

Distribution Pattern

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

Code Information

E2S47525 Lot 1301 and E2S47535 Lot 1301

Other recalls by Innovasis, Inc

  • Z-3163-2024 Class II — TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK (August 14, 2024)
  • Z-2062-2020 Class II — Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Pl (April 7, 2020)
  • Z-0644-2018 Class II — Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally (January 8, 2018)
  • Z-2153-2017 Class II — Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. P (May 5, 2017)
  • Z-0662-2016 Class II — Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat (December 7, 2015)