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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 Device Recall DePuy Mitek Tissue Liberator Blade Upsee related information
Date Initiated by FirmApril 15, 2013
Date PostedMay 09, 2013
Recall Status1 Terminated 3 on March 11, 2016
Recall NumberZ-1278-2013
Recall Event ID 64913
Product Classification Accessories,arthroscopic - Product Code NBH
ProductDePuy 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 
FEI Number 1221934
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Drive
Raynham MA 02767-5199
For Additional Information Contact
508-880-8100
Manufacturer Reason
for Recall		Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
FDA Determined
Cause 2		Process control
ActionDePuy 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 Commerce27 units
DistributionWorldwide 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 CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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