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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 64913
Product Type Devices
Status Ongoing
Recalling Firm DePuy Mitek, Inc., a Johnson & Johnson Co.
City Raynham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-15
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA including KY, NJ and Internationally to Argnetina, Australia, Belgium,Columbia, India, France, Japan, Jordan, Latvija, Israel, Korea, and Great Britain. For questions regarding this recall call 508-977-3813.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine. Lot number:13A01 Class II Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. 27 units Z-1278-2013