| Class 2 Device Recall NexGen Complete Knee Solution | |
Date Initiated by Firm | November 19, 2013 |
Date Posted | December 06, 2013 |
Recall Status1 |
Terminated 3 on May 06, 2015 |
Recall Number | Z-0462-2014 |
Recall Event ID |
66809 |
Product Classification |
Guide, surgical, instrument - Product Code HWT
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Product | NexGen Complete Knee Solution
CR Articular Surface Provisional-Yellow 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 00-5971-031-09 |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 345 E Main St Warsaw IN 46580-2746
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For Additional Information Contact | 800-613-6131 |
Manufacturer Reason for Recall | This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadvertently utilized during surgery, resulting in a delay. The associated implants would not be available due to the previous recall. |
FDA Determined Cause 2 | 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 | 684 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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