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U.S. Department of Health and Human Services

Class 2 Device Recall Timberline MPF Straight Split Tip Driver Short ("Driver")

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  Class 2 Device Recall Timberline MPF Straight Split Tip Driver Short ("Driver") see related information
Date Initiated by Firm November 04, 2013
Date Posted November 26, 2013
Recall Status1 Terminated 3 on December 29, 2015
Recall Number Z-0400-2014
Recall Event ID 66836
510(K)Number K123767  K131547  
Product Classification Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
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.
Code Information Lot No: TU00090, TU00157 and TU00242
Recalling Firm/
Manufacturer		 Lanx, Inc.
310 Interlocken Pkwy Ste 120
Broomfield CO 80021-3464
For Additional Information Contact Gary L. Turner
303-501-8402
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OVD and Original Applicant = LANX, INC.
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