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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 Device Recall NaturalKnee II System see related information
Date Posted March 20, 2014
Recall Status1 Terminated on March 24, 2015
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 IN 46580-2304
For Additional Information Contact
877-946-2761
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
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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