Z-1935-2014Class II

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

Name: Z-1935-2014 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 4+. 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-1935-2014
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 4+. 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 4+, includes the following Lot numbers: 61424996 61459959 61475129 61538052 61563971 61573791 61573792 61592090 61627207 61685463 61721674 61774165 61863139 61870152 61934692 61935096 61979044 61979045 62020278 62064940 62091727 62214673 62251567 62251568 62319307 62337924 62369795 62401020 62423841 62436412 62471736 62602816 62646169

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1935-2014
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)