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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
ā ļø Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer, Inc.
- Reason for Recall:
- Zimmer received a trend of complaints indicating corrosion of product.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
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.
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2585-2014
Related Recalls
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.