Devices

Device Recall NaturalKnee System Patella Bushings

  • Model / Serial
    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.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.
  • Product Description
    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
  • Manufacturer
    Zimmer, Inc.
  • 1 Event

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

3 devices with a similar name

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Device Recall NaturalKnee System Patella Bushings
  • Model / Serial
    Part Number 6290-00-690. Lots Manufactured by Zimmer: 1327524, 1339783, 1344879, 1346702, 1361955, 1368604, 1382204, 1386058, 1388164, 1429297, 1437553, 1441291, 1441897, 1451867, 1465171, 1470848, 1470849, 1472371, 1516851, 1530342, 1538118, 1547978, 1555574, 1560246, 1565076, 1583036, 1593277, 1594775, 1595926, 1598696, 1601040, 1606098, 1606511, 170454, 171324, 173342-09, 173342-10, 173342-2, 173342-3, 173342-9, 601863, 60319687, 60339959, 60415511, 60457440, 60539669, 60621386, 60732865, 60929928, 60946367, 60951770, 60961665, 60970630, 60994794, 61028392, 61080335, 61099775, 61171949, 61171950, 61208215, 61247557, 61444751, 61580595, 61732750, 61905939, 61924234, 61999723, 62156016, 62190266, 62220910, 62281030, 62298031, 62400882, 62597910, 640601, 669401, 691488, 741824, 783833, 784261, 789465, 789470, 791158, 796231, 796408, 802258, 803823, 810082, 825931-1, 825931-2, 831825-2, 863224-1, & 869009.   Lots Manufactured by Centerpulse: 93302, 95066, 95067, 95068, 95069, 97240, 97538, 97539, 99928, 1142822, 1147427, 1148798, 1151284, 1151286, 1151287, 1151288, 1153331, 1155442, 1155443, 1156670, 1156671, 1156672, 1157975, 1163692, 1163693, 1163694, 1163695, 1179240, 1179241, 1179242, 1179243, 1179244, 1190722, 1190723, 1190724, 1190725, 1190726, 1204516, 1204517, 1204518, 1204519, 1204537, 1204538, 1204539, 1204540, 1204541, 1204542, 1226013, 1238476, 1238477, 1238478, 1238479, 1238480, 1268798, 1268799, 1276896, 1276897, 1276898, 1276899, 1276900, 1307948, 1307949, 1312646, 1321254, 1324202, 1327524, 1332586, 1339783, 1340512, 1344879, 1346702, 1351210, 1361955, 1368604, 1373550, 1382204, 1386058, 1388164, 1429297, 1437553, 1441291, 1441897, 1451867, 1465171, 1470848, 1470849, 1472371, 1516851, 1530342, 1534065, 1538118, 1547978, 1555574, 1560246, 1565076, 1583036, 1583719, 1583720, 1593277, 1594775, 1595926, 1598696, 1601040, 1606098, & 1606511.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.
  • Product Description
    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. || 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.
  • Manufacturer
    Zimmer, Inc.
Device Recall NaturalKnee System Patella Bushings
  • Model / Serial
    Part Number: 6290-00-702. Lots Manufactured by Zimmer: 1324203, 1339203, 1346701, 1363348, 1373979, 1382208, 1385813, 1391253, 1421647, 1437118, 1440906, 1440943, 1451869, 1464915, 1469681, 1470531, 1472373, 1474483, 1538141, 1549267, 1552408, 1554291, 1554292, 1567743, 1598694, 1601263, 1601606, 1606096, 1606957, 170454, 172361, 173342-10, 173342-3, 173342-8, 173342-9, 596146, 597424, 60278535, 60305599, 60319668, 60426581, 60557544, 60712149, 60767845, 60931683, 60946366, 60947929, 60968638, 60970621, 60986924, 60986941, 61025150, 61037537, 61080336, 61080337, 61088939, 61099737, 61099765, 61105152, 61149082, 61240132, 61444750, 61588175, 61799358, 62007189, 62043610, 62123986, 62156012, 62192074, 62216444, 62253081, 62298037, 62304814, 62353344, 625039, 62575710, 640562, 731461, 752886, 783833, 784261, 784530, 789465, 789470, 791153, 791158, 796231, 802256, 803819, 810082, 825360-1, 825360-2, 833061-1, 863221-1, & 869007.  Lots Manufactured by Centerpulse: 10249, 95077, 95316, 95317, 95655, 95656, 96228, 97923, 97923, 97924, 97925, 97926, 97927, 97928, 1141805, 1142824, 1146537, 1146538, 1146673, 1154080, 1155982, 1160641, 1164199, 1164200, 1164232, 1164233, 1179234, 1179235, 1179236, 1179237, 1179238, 1190951, 1190952, 1190953, 1190954, 1190955, 1202697, 1202698, 1202699, 1202700, 1202701, 1202702, 1202703, 1202704, 1202705, 1202706, 1204532, 1238469, 1238470, 1238471, 1238472, 1238473, 1238474, 1238475, 1267914, 1268394, 1268395, 1268396, 1268397, 1299414, 1299415, 1299416, 1306226, 1306227, 1308485, 1308486, 1313079, 1324203, 1332585, 1332695, 1339203, 1340513, 1346701, 1351209, 1353798, 1363348, 1371128, 1373979, 1382208, 1382209, 1385813, 1391253, 1421647, 1437118, 1440906, 1440943, 1451869, 1464915, 1469681, 1470531, 1472373, 1474483, 1538141, 1549267, 1552408, 1554291, 1554292, 1567743, 1583624, 1583727, 1594531, 1594583, 1595925, 1598694, 1601263, 1601606, 1606096, 1606957, 1299414-A, 1299419-A, & 95315-A.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.
  • Product Description
    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. || 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.
  • Manufacturer
    Zimmer, Inc.
Device Recall NaturalKnee System Patella Bushings
  • Model / Serial
    Part Number: 6290-00-703. Lots Manufactured by Zimmer: 1324204, 1346689, 1361954, 1371127, 1374460, 1382191, 1386076, 1388163, 1421648, 1440890, 1441119, 1476227, 1476229, 1493832, 1493841, 1516853, 1530324, 1549264, 1549388, 1554288, 1554290, 1560754, 1563440, 1598691, 1598692, 1598693, 1598695, 1601605, 1606099, 1606510, 170675, 172016, 173342-09, 173342-10 , 173342-3 , 173342-5, 173342-9 , 601804, 60278820, 60310873, 60426582, 60541727, 60621363, 60641020, 60728521, 60763272, 60933532, 60936986, 60946365, 60947926, 60954309, 60961655, 60964904, 60970610, 60978734, 60998043, 61004755, 61019426, 61025143, 61037534, 61092670, 61092673, 61092674, 61099693, 61188779, 61208208, 61244656, 61444749, 61588176, 61626531, 61815323, 618303, 61910780, 62007198, 62159771, 62238171, 62298008, 62495684, 672559, 691440, 739625, 751350, 784259, 784516, 786652, 791148, 795930, 802251, 803806, 825358-2, 831816-1, 863218-1, 865553, 866726, & 869004.   Lots Manufactured by Centerpulse: 9878, 11486, 95318, 95657, 97415, 98273, 98697, 98698, 98699, 98700, 1142825, 1146539, 1147429, 1155440, 1155441, 1163886, 1163887, 1163888, 1163889, 1180631, 1180632, 1180633, 1180634, 1180635, 1190945, 1190946, 1190947, 1190948, 1190949, 1190950, 1204513, 1204514, 1204515, 1204529, 1204530, 1204531, 1204532, 1204533, 1204534, 1204535, 1204536, 1216592, 1238464, 1238465, 1238466, 1238467, 1238468, 1267379, 1267380, 1267381, 1267383, 1267384, 1267385, 1299603, 1299604, 1306224, 1306225, 1307950, 1307951, 1312647, 1324204, 1331517, 1332138, 1339782, 1340514, 1346689, 1353798, 1361954, 1371127, 1373553, 1374460, 1382191, 1386076, 1388163, 1421648, 1439178, 1440890, 1441119, 1476227, 1476228, 1476229, 1493832, 1493833, 1493841, 1498789, 1503345, 1516853, 1530324, 1533357, 1549264, 1549388, 1554288, 1554290, 1560754, 1563440, 1583518, 1583721, 1583722, 1593708, 1595927, 1598691, 1598692, 1598693, 1598695, 1601605, 1606099, 1606510, & 95658-A.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.
  • Product Description
    Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. || 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.
  • Manufacturer
    Zimmer, Inc.