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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

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

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
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