Class 2 Device Recall NaturalKnee II System

• Date Initiated by Firm: February 25, 2014
• Date Posted: March 20, 2014
• Recall Status: 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.