Class 2 Device Recall Timberline Anchored Lateral Retractable Drill

• Date Initiated by Firm: August 22, 2013
• Date Posted: January 15, 2015
• Recall Status: Terminated 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
• FEI Number: 3012447612
• 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: 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