Recall Z-0411-2014— Ebi, Llc

Class II FDA medical device recall by Ebi, Llc, initiated 2013-09-24, terminated 2015-05-15. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case..

Recalling firm

Ebi, Llc

Classification

Class II

Status

Terminated

Initiated

2013-09-24

Terminated

2015-05-15

Firm location

Parsippany, NJ, United States

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