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U.S. Department of Health and Human Services

Class 2 Device Recall NaturalKnee System Patella Bushings

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 Class 2 Recall
NaturalKnee System Patella Bushings
see related information
Date Posted September 04, 2014
Recall Status1 Open
Recall Number Z-2585-2014
Recall Event ID 68655
Premarket Notification
510(K) Number
K073286 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
Code Information Part Number 6290-00-704. Lots Manufactured by Zimmer: 1137602, 1324205, 1331331, 1346218, 1351208, 1368598, 1373552, 1376006, 1382199, 1386059, 1422626, 1426895, 1438006, 1441899, 1475757, 1475758, 1478938, 1493445, 1517176, 1525953, 1525954, 1549263, 1551990, 1554289, 1556787, 1560245, 1596097, 1601264, 1601980, 1606097, 1606956, 170675, 172228, 173342-3, 173342-8, 173342-9, 593336, 597424, 60259011, 60293370, 60305590, 60380932, 60398259, 60607433, 60671091, 60704501, 60744843, 60924671, 60931675, 60946362, 60949827, 60956490, 60961653, 60973615, 60983070, 60987243, 61010771, 61092652, 61099690, 611105, 61132248, 61240154, 61240155, 61513545, 61750140, 62028651, 62130964, 62238170, 62477497, 625041, 689492, 747883, 783836, 784561, 789471, 791165, 796410, 802259, 803825, 825355-1, 825355-2, 831825-1, 863226-1, 863226-2,& 9907272. Lots Manufactured by Centerpulse: 9827, 10406, 95319, 95659, 95660, 95661, 96666, 97909, 97910, 97911, 97918, 97919, 97920, 97921, 97922, 1137602, 1141806, 1142826, 1142827, 1146540, 1147430, 1148802, 1155438, 1155439, 1164234, 1164235, 1164236, 1164237, 1180626, 1180627, 1180628, 1180629, 1180630, 1190942, 1190943, 1190944, 1200830, 1200831, 1200832, 1200833, 1200834, 1200835, 1200836, 1200837, 1200838, 1200839, 1200840, 1232870, 1232871, 1232872, 1232873, 1232874, 1265021, 1265022, 1265023, 1265024, 1265025, 1265026, 1299412, 1299413, 1307097, 1307745, 1307746, 1313080, 1321261, 1324205, 1331331, 1331516, 1340515, 1346218, 1351208, 1353797, 1361953, 1368598, 1373552, 1376006, 1382199, 1386059, 1388166, 1422626, 1426895, 1438006, 1441899, 1475757, 1475758, 1478938, 1493445, 1517176, 1525953, 1525954, 1549263, 1551990, 1554289, 1556787, 1560245, 1583307, 1583622, 1583623, 1594529, 1596097, 1601264, 1601980, 1606097, 1606956, & 1346218-B.
Recalling Firm/
Manufacturer
Zimmer, Inc.
1800 W Center St
Warsaw, Indiana 46580-2304
Manufacturer Reason
for Recall
Zimmer received a trend of complaints indicating corrosion of product.
FDA Determined
Cause 2
DESIGN: Device Design
Action Zimmer issued an Urgent Medical Device Recall-Lot Specific notification via e-mail/letter dated July 19, 2014, to all affected customers. The notification identified the product the problem and the action needed to be taken by the customer. All distributors were notified via electronic mail. Hospital risk managers and surgeons, as well as distributors with affected inventory were notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory as well as identifying hospitals and surgeons who have previously used the affected product. Distributors are to return on-hand affected products to Zimmer, and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative. If you have questions or concerns regarding this recall please call the customer call center at 1-877-946-2761.
Quantity in Commerce 8638 distribution events
Distribution Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.
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) Database 510(K)s with Product Code = JWH and Original Applicant = ZIMMER, INC.
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