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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 64486
Product Type Devices
Status Ongoing
Recalling Firm Bacterin International, Inc.
City Belgrade
State MT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-21
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern USA Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler B100164 and B110115 Class II The firm's retesting procedure was not validated. 165 Z-1138-2013