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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 Recall
Columbus 4IN1 Femoral Cutting Guide M3 Instrument
see related information
Date Posted October 18, 2012
Recall Status1 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
Recalling Firm/
Manufacturer
Aesculap, Inc.
3773 Corporate Pkwy
Center Valley, Pennsylvania 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
TRAINING: Employee Error
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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