Ebi, Llc: Medical Device Recall in 2013 - (Recall #: Z-0411-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion

Product Classification:

Class II

Date Initiated: September 24, 2013

Date Posted: December 4, 2013

Recall Number: Z-0411-2014

Event ID: 66654

Reason for Recall:

Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.

Status: Terminated

Product Quantity: 2 units

Code Information:

Device listing # D090878 Catalog # LV00407 Lot #184090

Distribution Pattern:

US Distribution to CA

Voluntary or Mandated:

Voluntary: Firm initiated