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U.S. Department of Health and Human Services

Class 2 Device Recall NaturalKnee II Unicompartmental Knee System

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  Class 2 Device Recall NaturalKnee II Unicompartmental Knee System see related information
Date Initiated by Firm February 25, 2014
Date Posting Updated March 20, 2014
Recall Status1 Terminated 3 on March 24, 2015
Recall Number Z-1252-2014
Recall Event ID 67503
510(K)Number K033810  
Product Classification Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
Product Natural-Knee¿ II Unicompartmental Knee System:
UNI ALL-POLY TIB SZ 1-7mm
UNI ALL-POLY TIB SZ 1-9mm

Code Information Item Number, 613001007, 613001009.
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 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.
510(K) Database 510(K)s with Product Code = HRY and Original Applicant = CENTERPULSE ORTHOPEDICS, INC.
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