Zimmer, Inc.: 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.

Recall number

Z-2582-2014

Recalling firm

Zimmer, Inc.

Product

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.

Status

Terminated

Initiated

2014-07-10

Posted

2014-09-04

Terminated

2015-08-20

Reason

Zimmer received a trend of complaints indicating corrosion of product.

Root cause

Device Design

Action

Zimmer issued an Urgent Medical Device Recall-Lot Specific notification via e-mail/letter dated July 19, 2014, to all affected customers. The notification identified the product the problem and the action needed to be taken by the customer. All distributors were notified via electronic mail. Hospital risk managers and surgeons, as well as distributors with affected inventory were notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory as well as identifying hospitals and surgeons who have previously used the affected product. Distributors are to return on-hand affected products to Zimmer, and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative. If you have questions or concerns regarding this recall please call the customer call center at 1-877-946-2761.

Quantity

8638 distribution events

Distribution

Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.

Lot, serial or model codes

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.

510(k) numbers

["K073286"]

PMA numbers

not on file

Product code

JWH

Firm FEI

1000220733

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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