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U.S. Department of Health and Human Services

Class 2 Device Recall Timberline Anchored Lateral Retractable Drill

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  Class 2 Device Recall Timberline Anchored Lateral Retractable Drill see related information
Date Initiated by Firm August 22, 2013
Date Posted January 15, 2015
Recall Status1 Terminated 3 on March 13, 2015
Recall Number Z-0982-2015
Recall Event ID 70056
510(K)Number K123767  
Product Classification Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
Product Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102.

Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
Code Information Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25, 2013 and TU00155: July 31, 2013
Recalling Firm/
Manufacturer		 Biomet Spine, LLC
310 Interlocken Pkwy Ste 120
Broomfield CO 80021-3464
For Additional Information Contact Mike Medina
303-443-7500 Ext. 244
Manufacturer Reason
for Recall		 The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.
FDA Determined
Cause 2		 Component design/selection
Action Distributors and Direct Sales Reps notified via letter to return product.
Quantity in Commerce 15
Distribution Distributed in PR and the states of NY, AZ, TN, TX, and CA.
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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