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Recall Observatory FDA recall evidence

Device product

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

Z-0411-2014

September 24, 2013

Class II

Product summary

Firm
Ebi, Llc
Event
Event 66654
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0411-2014

Official wording

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

Code information: Device listing # D090878 Catalog # LV00407 Lot #184090

Distribution pattern: US Distribution to CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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