FDAFDA · Food and drugs·Recall number Z-1262-2014
Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1 ALL POLY ULTRA TIB RT SZ1 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB RT SZ2 ALL POLY ULTRA TIB LT SZ3 ALL POLY ULTRA TIB RT SZ3 ALL POLY ULTRA TIB RT SZ5
Published March 26, 2014 · Recall initiated: February 25, 2014
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
A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
- Lot
- Item Number 621800809 621801809 621801819 621801913 621801916 621810816 621810909 621820809 621820811 621820911 621830811 621830909 621850916
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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