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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Event Detail

Event ID 62326
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 2011-09-19
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Nationwide Distribution including the states of: Arizona. and California.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium. Lot numbers E203050779 and E383055709. Class II Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart. 5 each Z-2077-2012