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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Mitek Tissue Liberator Blade Up

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 Class 2 Recall
DePuy Mitek Tissue Liberator Blade Up
see related information
Date Posted May 09, 2013
Recall Status1 Open
Recall Number Z-1278-2013
Recall Event ID 64913
Product Classification Accessories,Arthroscopic - Product Code NBH
Product 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.
Code Information Lot number:13A01
Recalling Firm/
Manufacturer
DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Drive
Raynham, Massachusetts 02767-5199
Manufacturer Reason
for Recall
Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action DePuy Synthes sent an Urgent Voluntary Product Recall letter dated April 15, 2013, to all affected customers. The letter iidentified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check all inventories to locate and return the affected product. For returns customers were instructed call 1-877-379-4871 to obtain a goods authorization (RGA) number. Affected product should be returned to: Mitek Sports Medicine ATTN: Mitek Complaints 325 Paramouont Drive Rayham, MA 02067 For questions customers were instructed to call 1-877-379-4871.
Quantity in Commerce 27 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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