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U.S. Department of Health and Human Services

Class 2 Device Recall NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS

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 Class 2 Recall
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS
see related information
Date Posted September 13, 2010
Recall Status1 Terminated on March 28, 2011
Recall Number Z-2416-2010
Recall Event ID 55876
Premarket Notification
510(K) Number
K043101 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4+ (Plus), sterile, REF 00-5950-037-12, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
Code Information 60284257, 60331382, 60467849, 60621126, 60649154, 60732157, 60775802, 60923137, 61006365 and 61029266
Recalling Firm/
Manufacturer
Zimmer Inc.
1800 W Center St
Warsaw, Indiana 46580-2304
Manufacturer Reason
for Recall
The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm, Zimmer, Inc., sent an "URGENT DEVICE CORRECTION" letter dated April 26, 2010, to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to destroy or disregard all previous versions of the surgical technique, review the attached revised surgical technique to familiarize yourself with the modifications and warnings, and complete and return the Health Care Professional Dcoumentation Form via fax to Zimmer, Inc. at (574) 372-4265. (Note: Zimmer made a modification to the surgical technique and instructions for use. They added a warning to fully cement and pressurize the anterior and posterior surfaces of the tibial component, and to strongly recommend the use of a drop down stem extension. This change was completed and approved on April 23, 2010.) For questions please contact Zimmer at 1-877-946-2761.
Quantity in Commerce 68,384 all products
Distribution Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ZIMMER, INC.
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