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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Columbus 4IN1 Femoral Cutting Guide M3 Instrument see related information
Date Initiated by Firm May 09, 2012
Date Posted October 18, 2012
Recall Status1 Terminated 3 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
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 2		 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.
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