Z-1937-2014Class II

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing...

Name: Z-1937-2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing...
Creator: Zimmer, Inc.
Published: 2014-05-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-05-19 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of... on 2014-05-19. FDA classified it as Class II and gives the reason as "Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1937-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-19
Posted: 2014-06-27
Terminated: 2015-10-29
Recalling firm: Zimmer GmbH
Product: NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
Quantity in commerce: 41,180 total
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
Product codes and lots: Size 6, includes the following Lot Numbers: 370319 37213647 37218135 37218727 37219556 37220950 61414605 61414606 61442322 61451224 61451225 61451226 61479488 61479489 61479490 61518197 61518198 61518199 61538053 61543978 61592093 61592094 61627261 61643938 61672569 61682157 61685470 61721675 61721676 61774189 61774190 61774191 61774195 61863158 61863159 61863160 61863161 61863162 61979034 61979035 62016163 62022560 62037896 62041306 62041308 62069549 62077856 62141261 62143609 62168186 62177113 62227421 62227422 62251569 62251570 62261977 62261978 62326316 62330687 62341281 62369796 62369797 62377652 62473295 62473296 62602804 62602805 62602806 62602807 62602808

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1937-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1931-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1932-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1933-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1934-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1935-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1936-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1937-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1938-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1939-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27

Product code JWH

K043101Class IINexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem ExtensionsZimmer, Inc. / cleared 2005-03-07

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)