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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen Complete Knee Solution

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 Class 2 Recall
NexGen Complete Knee Solution
see related information
Date Posted December 06, 2013
Recall Status1 Open
Recall Number Z-0461-2014
Recall Event ID 66809
Product Classification Template - Product Code HWT
Product NexGen® Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.
Code Information Part Number 00-5971-020-09
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue. Since the initiation of this recall, five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Given this, all lots of these additional instruments are now being recalled as well. There is the potential for these devices
FDA Determined
Cause 2
DESIGN: Labeling Design
Action Zimmer sent an Urgent Medical Device Recall Notice dated November 19, 2013, to all affected customers. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product will be removed by a Zimmer Sales representative, Question should be directed to 1-877-946-2761 8a.m - 5 p.m. EST. For questions regarding this recall call 800-613-6131.
Quantity in Commerce 638 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.
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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