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U.S. Department of Health and Human Services

Medical Device Recalls

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 Class 2 Recall
NexGen CompleteKnee Solution
see related information
Date Posted November 26, 2012
Recall Status1 Open
Recall Number Z-0437-2013
Recall Event ID 63544
Premarket Notification
510(K) Number
K872379 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen?? system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen 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; salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Code Information Catalog 00-5986-047-02, lots 62049114 and 62045235.
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
For Additional Information Contact Dawn Kindle
574-372-4807
Manufacturer Reason
for Recall
Zimmer is initiating a lot specific recall of the NexGen? Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a result, the devices may contain residual particulate from the manufacturing process. Risks include: Allergic reaction due to the foreign material or late onset
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control
Action Zimmer sent an Urgent Medical Device Recall letter dated September 21, 2012, to all affected customers. The letter identifiedthe product, the problem, and the action to be taken by the customer. Customers were instructed to locate and quarantine the affected product. Customers were to return the affected product along with the completed Inventory Return Certificate Form. If product was further distributed the Recall Letter should be forwarded to their customers. Product was to be returned to USA accounts - Zimmer Product Service Department, 1777 West Center St. Warsaw, IN 46580. If product has been implanted, affected surgeons will be notified. For questions regarding this recall call 574-372-4807.
Quantity in Commerce 123 worldwide (33 USA)
Distribution Worldwide Distribution - USA including AZ,CA, FL, IA, IL, IN, MO, NE, NJ, NY, OH, PA, WA. Internationally to Thailand, Canada, Germany, France, UK, Hungary, Netherlands, Russian Fed, and Sweden,
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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