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U.S. Department of Health and Human Services

Class 2 Device Recall ArthroCare Knot Pusher

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 Class 2 Recall
ArthroCare Knot Pusher
see related information
Date Posted January 09, 2014
Recall Status1 Open
Recall Number Z-0652-2014
Recall Event ID 67087
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
Code Information Catalog #25-3011, Lot #1049402
Recalling Firm/
Manufacturer
ArthroCare Medical Corporation
7000 W William Cannon Dr
Austin, Texas 78735-8509
Manufacturer Reason
for Recall
A sharp edge on the cannulated tip of the device may damage or cut a suture.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action All consignees were provided with written notice via Urgent Recall Notification dated December 9, 2013 with delivery confirmation. In addition, the firm plans on notifying the EU, and the governments of France, Germany, Switzerland, and Spain. The firm will also notify the Swedish government because the firm's EU representative is located in Sweden.
Quantity in Commerce 76
Distribution Worldwide distribution: US (nationwide) including states of: CA, FL, GA, IL, IN, KY, MN, MO, NY, OH, TX, and WI. Internationally to: Canada, France, Germany, Spain, and Switzerland.
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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