Device Recall NaturalKnee System Patella Bushings

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.
  • Description du dispositif
    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