Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Shortened Plug Driver Recalled by Ebi, Llc Due to Biomet received a complaint on 5/20/2013 reporting that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ebi, Llc directly.
Affected Products
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
Quantity: 2 units
Why Was This Recalled?
Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
Where Was This Sold?
This product was distributed to 1 state: CA
About Ebi, Llc
Ebi, Llc has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report