FDAFDA · Food and drugs·Recall number Z-0463-2014
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.
Published December 18, 2013 · Recall initiated: November 19, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- 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.
- Lot
- Part Number 00-5971-041-09
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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