Class 2 Device Recall Columbus 4IN1 Femoral Cutting Guide M3 Instrument

• Date Initiated by Firm: May 09, 2012
• Date Posted: October 18, 2012
• Recall Status: Terminated on January 15, 2014
• Recall Number: Z-0082-2013
• Recall Event ID: 63223
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
• Code Information: NQ083R
• FEI Number: 2916714
• Recalling Firm/ Manufacturer: Aesculap, Inc.; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: Customer Support; 800-234-9179 Ext. 5067
• Manufacturer Reason for Recall: The manufacturer informed the recalling firm of a potential laser marking error in size identification on two Columbus 4-IN-1 Femoral Cutting Guide Instruments. The guides are correctly dimensioned, but the laser markings have been incorrectly etched.
• FDA Determined Cause: Process change control
• Action: Both consignees were notified verbally on May 15, 2012 and asked to inspect their inventory for the recalled items, remove the mislabeled instruments and return them to the recalling firm. Both mislabeled instruments were returned to the firm. Customer questions were directed to (610) 984-9074.
• Quantity in Commerce: 2
• Distribution: Within the US, product was distributed to PA 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.