Z-0400-2014Class II

LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model...

Name: Z-0400-2014 LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model...
Creator: Lanx, Inc.
Published: 2013-11-04
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2013-11-04 / Terminated / root cause: manufacturing process

FDA source

Lanx, Inc. began a recall of LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an... on 2013-11-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0400-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-04
Posted: 2013-11-26
Terminated: 2015-12-29
Recalling firm: Highridge Medical, LLC
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.
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: LANX sent an URGENT: Recall letter dated November 5, 2013, to all affected customers via Federal Express, Overnight delivery. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected product to the firm. Customers with questions were instructed to contact Field Inventory Management. For questions regarding this recall call 303-501-8402.
Quantity in commerce: 25 units
Distribution: Nationwide Distribution including AZ, PA, WI, NY, TX, PR, and TN.
Product codes and lots: Lot No: TU00090, TU00157 and TU00242

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0400-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0400-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

Product code OVD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)