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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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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
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.

Product Detail

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