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U.S. Department of Health and Human Services

Class 2 Device Recall CLOSED KNOT PUSHER

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  Class 2 Device Recall CLOSED KNOT PUSHER see related information
Date Initiated by Firm August 02, 2010
Date Posted October 14, 2010
Recall Status1 Terminated 3 on August 20, 2012
Recall Number Z-0059-2011
Recall Event ID 56589
Product Classification Pusher, socket - Product Code HXO
Product Closed knot pusher REF 902813, Biomet Sports Medicine, Warsaw, IN.
The device is intended to push knots down a limb of suture.
Code Information 098750, 278290, 538080, 666270, 864100 and 948870.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Mary Johnson
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 The firm has received four complaints that the closed knot pusher is missing a radius which contributes to sutures being cut during surgery.
FDA Determined
Cause 2		 Device Design
Action Biomet Sports Medicine sent URGENT MEDICAL DEVICE RECALL NOTICES dated 8/2/2010 to its customers and distributors. The notices stated that the use of the device should be discontinued and the products returned to Biomet. Healthcare professionals and consumers were to report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online at www.fda.gov/MedWatch/report.htm, by regular mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or by phone at (800)FDA-1088 or Fax (800)FDA-0178. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8AM to 5PM.
Quantity in Commerce 101
Distribution Worldwide Distribution - USA, including FL, NY, VA, CA, GA, AL, PA, MI, LA, KS, SD, KY, TX, AR, and WV, and the countries of Belgium, Italy, Argentina, Poland, Netherlands, Turkey and Portugal.
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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