NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 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.
Recall
- Recall Number
- Z-0463-2014
- Event Number
- 66809
- Firm
- Zimmer, Inc.
- FEI Number
- 1000220733
- Product Code
- HWT
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- November 19, 2013
- Posted
- December 6, 2013
- Terminated
- May 6, 2015
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 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.
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.
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.
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.
439 units