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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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Product Detail

Product Description Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
Recall Number Z-0082-2013
Classification Class II
Code Info NQ083R
Product Distributed Qty 2
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.

Event Detail

Event Id 63223
Product Type Devices
Status Ongoing
Recalling Firm Aesculap, Inc.
City Center Valley
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-09
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Within the US, product was distributed to PA and TN.