Home / Recalls / Biomet Spine, LLC / Z-2759-2015

Z-2759-2015 Class II Terminated

Recalled by Biomet Spine, LLC — Broomfield, CO

Recall Details

Product Type
Devices
Report Date
September 16, 2015
Initiation Date
July 22, 2015
Termination Date
December 10, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49

Product Description

Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.

Reason for Recall

Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.

Distribution Pattern

Worldwide Distribution: US (nationwide) in states of: NY, MO, WI, IN, CA, NC, and OH, and to countries of: Japan and Netherlands.

Code Information

P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220

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