Z-2583-2014Class II

Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the...

Name: Z-2583-2014 Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the...
Creator: Zimmer, Inc.
Published: 2014-07-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-07-10 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the... on 2014-07-10. FDA classified it as Class II and gives the reason as "Zimmer received a trend of complaints indicating corrosion of product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2583-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-10
Posted: 2014-09-04
Terminated: 2015-08-20
Recalling firm: Zimmer GmbH
Product: 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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Zimmer received a trend of complaints indicating corrosion of product.
Root cause tag: design
FDA 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 in commerce: 8638 distribution events
Distribution: Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2583-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2582-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-04
Z-2583-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-04
Z-2584-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-04
Z-2585-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-04

Product code JWH

K073286Class IIGender Solutions Natural-Knee Flex SystemZimmer, Inc. / cleared 2008-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)