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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- 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 6290-00-690. 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.
Product Codes/Lot Numbers:
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.
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2582-2014
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.