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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Event Detail

Event ID 66536
Product Type Devices
Status Ongoing
Recalling Firm Aesculap, Inc.
City Center Valley
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-19
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed in FL and MD.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7 lots: 51468773, 51447588, 51468302, 51503760, 51571394, 51585136, 51447597 Class II The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible. 24 Z-0492-2014