Home / Recalls / Ebi, Llc / Z-0954-2013

Z-0954-2013 Class II Terminated

Recalled by Ebi, Llc — Parsippany, NJ

Recall Details

Product Type
Devices
Report Date
March 27, 2013
Initiation Date
February 7, 2013
Termination Date
December 7, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
59 units.

Product Description

Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.

Reason for Recall

Increased risk of failure at the driver tip during screw insertion or removal.

Distribution Pattern

Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.

Code Information

Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.

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