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U.S. Department of Health and Human Services

Class 2 Device Recall NaturalKnee II System

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 Class 2 Recall
NaturalKnee II System
see related information
Date Posted March 20, 2014
Recall Status1 Open
Recall Number Z-1255-2014
Recall Event ID 67503
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Natural-Knee® II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT SZA/11M ULTRA CONG INS RT SZA/13M ULTRA CONG INS RT SZA/19M ULTRA CONG INS LT SZB/13M ULTRA CONG INS LT SZB/16M ULTRA CONG INS RT SZB/19M ULTRA CONG INS RT SZB/22M NKII ROT PLTFM U/C INS, 9 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 ALL POLY CONG TIB LT SZ00 ALL POLY CONG TIB LT SZ0/ ALL POLY CONG TIB LT SZ0/ ALL POLY CONG TIB RT SZ0/ ALL POLY CONG TIB RT SZ0/ ALL POLY CONG TIB LT SZ1/ ALL POLY CONG TIB LT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB LT SZ4/ ALL POLY CONG TIB LT SZ4/ ALL POLY CONG TIB RT SZ4/ ALL POLY CONG TIB RT SZ4/ ALL POLY CONG TIB RT SZ5/ PS TIB INS RT SZ1/2 16MM PS TIB INS RT SZ1/2 19MM PS TIB INS LT SZ00/0 19MM PS TIB INS RT SZ00/0 11MM PS TIB INS RT SZ00/0 16MM
Code Information Item Number 625001609 625001613 625001619 625001709 625001711 625001713 625001719 625002613 625002616 625002719 625002722 630809510 630811410 630811510 630813410 630813510 630816210 630816410 630816510 630819010 630819110 630819210 630819310 630819410 630819510 635000009 635001009 635001011 635001111 635001116 635002009 635002011 635002109 635002111 635002113 635003009 635003011 635003013 635003016 635003109 635003113 635003116 635004009 635004011 635004016 635004111 635004113 635004119 635005013 635005019 635005111 635005116 635006109 670501916 670501919 670503819 670503911 670503916
Recalling Firm/
Manufacturer
Zimmer, Inc.
1800 W Center St
Warsaw, Indiana 46580-2304
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Storage
Action 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 corporatequality.postmarket@zimmer.com. 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 3638 units
Distribution 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.
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