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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Recall Number Z-1377-2013
Classification Class II
Code Info Lots numbers: D433040800, D403040236, D383039472.
Product Distributed Qty 1,827 burrs
Reason For Recall Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

Event Detail

Event Id 64886
Product Type Devices
Status Ongoing
Recalling Firm The Anspach Effort, Inc.
City Palm Beach Gardens
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-03-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.
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