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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

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

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 Telephone
Distribution Pattern Distributed in FL and MD.