Biomet Spine, LLC: Medical Device Recall in 2015 - (Recall #: Z-2759-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 22, 2015

Date Posted: September 16, 2015

Recall Number: Z-2759-2015

Event ID: 71877

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.

Status: Terminated

Product Quantity: 49

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated