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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen Complete Knee Solutions Stemmed Tibial Component Precoat

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 Class 2 Recall
NexGen Complete Knee Solutions Stemmed Tibial Component Precoat
see related information
Date Posted December 11, 2013
Recall Status1 Open
Recall Number Z-0480-2014
Recall Event ID 66714
Premarket Notification
510(K) Number
K933785 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product NexGen® Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. 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.
Code Information 00-5980-037-02; lot 6228417
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010.
FDA Determined
Cause 2
DESIGN: Device Design
Action All distributors will be notified via electronic mail. Hospital risk managers and distributors with affected inventory will also be notified via courier. Surgeons that have implanted this manufacturing lot will be identified and notified by the distributor. Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory, as well as identifying and notifying surgeons that have implanted this manufacturing lot. Distributors will return on-hand affected products to Zimmer and ensure all of their products are accounted for using Attachment 1 provided in the letter. Distributors are to complete and return Attachment 2 indicating which surgeons have implanted the product and to which they have provided notice to. Hospitals that received direct shipments from Zimmer will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product and returning it to their Zimmer sales representative. Communications outside of the United States will occur approximately two weeks after the United States communications. Zimmer will conduct effectiveness checks in the following way: Distributors/Hospitals o 100% of the FedEx notifications will be accounted for o An inventory certification form will need to be returned from each distributor that certifies that all available affected product from their territory has been returned. o Additional notifications via email and FedEx will be sent to those who have not completed the required certification form o Accounts will be deemed unresponsive after 3 attempts. Further questions please call 800-613-6131.
Quantity in Commerce 128 units
Distribution Worldwide Distribution - USA (nationwide) including the states of CA, IN, OH, GA, WI, IA, NE, NJ, PA, NY, MD, NC, AZ, NM, TX, CO, IL, AL, MI, WA, FL and KS, and the countries of China, Japan and Taiwan.
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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