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Recall Observatory FDA recall evidence

Device 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.

Z-0400-2014

November 04, 2013

Class II

Product summary

Firm
Lanx, Inc.
Event
Event 66836
Status
Terminated
Classification
Class II
Quantity
25 units
Official record key
device-enforcement:Z-0400-2014

Official wording

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.

Code information: Lot No: TU00090, TU00157 and TU00242

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.