Lanx, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0400-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 4, 2013

Date Posted: December 4, 2013

Recall Number: Z-0400-2014

Event ID: 66836

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.

Status: Terminated

Product Quantity: 25 units

Code Information:

Lot No: TU00090, TU00157 and TU00242

Distribution Pattern:

Nationwide Distribution including AZ, PA, WI, NY, TX, PR, and TN.

Voluntary or Mandated:

Voluntary: Firm initiated