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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
Recall Number Z-0715-2014
Classification Class II
Code Info ALL LOTS for product code 18-0001
Product Distributed Qty 492 (321 US)
Reason For Recall Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.

Event Detail

Event Id 67177
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 2012-03-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.