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U.S. Department of Health and Human Services

Class 2 Device Recall InnerVue Diagnostic Scope System

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  Class 2 Device Recall InnerVue Diagnostic Scope System see related information
Date Initiated by Firm February 10, 2011
Date Posted March 07, 2011
Recall Status1 Terminated 3 on August 27, 2013
Recall Number Z-1589-2011
Recall Event ID 57965
510(K)Number K072879  
Product Classification laparoscope - Product Code HRX
Product Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE
Code Information PART NUMBER 922141, LOT NUMBERS-649680, 818630, 390060, 968890, 783990, 784000
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact Mary Johnson
800-348-9500 Ext. 3755
Manufacturer Reason
for Recall		 The cannula could not be connected to the scope and scopes disengage during use. The outer hub of Innervue scopes may become detached from the inner hub of the scopes during assembly of the scope to the Innervue hand piece. This condition may prevent the Innervue scope from being securely attached to the Innervue hand piece.
FDA Determined
Cause 2		 Process design
Action On 2/10/2011, Biomet issued an "URGENT MEDICAL DEVICE NOTICE" to their Direct Accounts instructing customers to identify and discontinue use of the recalled products and return them to Biomet. Response forms were provided.
Quantity in Commerce 264
Distribution Distribution USA nationwide and to the Netherlands
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = BIOMET ORTHOPEDICS, INC.
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