Recall Z-0400-2014— Lanx, Inc.

Name: FDA recall Z-0400-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-04

Class II · Terminated

Class II FDA medical device recall by Lanx, Inc., initiated 2013-11-04, terminated 2015-12-29. It names 2 FDA 510(k) clearances: K131547, K123767. Product: LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae.. Reason: Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized..

Recalling firm: Lanx, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-04
Terminated: 2015-12-29
Firm location: Broomfield, CO, United States

510(k) clearances named in this recall

2 on FDA's record

K131547 — LANX FUSION SYSTEMLanx, Inc.·cleared 2013-07-12
K123767 — LANX FUSION SYSTEM- SALanx, Inc.·cleared 2013-03-18

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

LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae.

Reason for recall

Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized.

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