| ||Class 2 Device Recall NaturalKnee II System |
||March 20, 2014
||Terminated on March 24, 2015
|Recall Event ID
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer -
||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
1800 W Center St
|For Additional Information Contact
|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.
||Beginning 2/25/2014 all distributors were notified via electronic mail. Hospital risk managers and distributors, surgeons with affected inventory will also be notified via courier or direct mail. The Urgent Lot Specific Recall Notice identified the issue and responsibilities. Distributors were asked to locate and remove the affected product in their territory, as well as identifying hospitals and surgeons who have previously implanted the affected product. Distributors were asked to return on-hand affected products to Zimmer and ensure all of their products are accounted for using the form provided in the letter and email it back to firstname.lastname@example.org.
Hospital risk managers and surgeons were asked to locate affected product and return it to their Zimmer sales representative. Questions or concerns should be addressed to customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST
Communications outside of the United States will occur approximately two weeks after the United States communications.
100 % effective checks will be done.
|Quantity in Commerce
||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.
|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.
510(K)s with Product Code = JWH and Original Applicant = INTERMEDICS ORTHOPEDICS