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U.S. Department of Health and Human Services

Class 2 Device Recall EZPass Nylon Monofilament Single Pack

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  Class 2 Device Recall EZPass Nylon Monofilament Single Pack see related information
Date Initiated by Firm April 15, 2014
Date Posted June 16, 2014
Recall Status1 Terminated 3 on July 07, 2015
Recall Number Z-1802-2014
Recall Event ID 68216
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
Code Information Part numbers 110007379 Lot 060830 and 258920,
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
FDA Determined
Cause 2		 Device Design
Action On 2/28/14, customers received a letter stating these devices have been recalled following an investigation which identified that the nitinol wire or monofilament may buckle within the EzPass Suture Passer and become kinked making the wire/monofilament difficult to use. The letter also stated, there is no adverse health outcome expected for the patient and this action requires the immediate location and discontinued use of the product and its return to Biomet.
Quantity in Commerce 100 units
Distribution Nationwide Distribution.
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.
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