Z-0411-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2013
- Initiation Date
- September 24, 2013
- Termination Date
- May 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
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
Reason for Recall
Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
Distribution Pattern
US Distribution to CA
Code Information
Device listing # D090878 Catalog # LV00407 Lot #184090