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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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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
Distribution Pattern Within the US, product was distributed to PA and TN.

Product Detail

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