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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- 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: 6290-00-703. 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.
Product Codes/Lot Numbers:
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.
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2584-2014
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.