Recall Z-2759-2015— Biomet Spine, LLC

Name: FDA recall Z-2759-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-22

Class II · Terminated

Class II FDA medical device recall by Biomet Spine, LLC, initiated 2015-07-22, terminated 2015-12-10. It names one FDA 510(k) clearance: K122378. Product: 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: 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..

Recalling firm: Biomet Spine, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-07-22
Terminated: 2015-12-10
Firm location: Broomfield, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K122378 — NEXTGEN ALTIUS OCT SYSTEMBiomet Spine (Aka Ebi, LLC)·cleared 2012-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.