Z-2115-2017Class II

NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty

Name: Z-2115-2017 NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty
Creator: Zimmer Biomet, Inc.
Published: 2017-04-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-04-28 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty on 2017-04-28. FDA classified it as Class II and gives the reason as "Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2115-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-28
Posted: 2017-05-18
Terminated: 2018-07-03
Recalling firm: Zimmer GmbH
Product: NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Zimmer Biomet is conducting a voluntary recall for two lots of the NexGen Offset Stem Extension implants following product complaints indicating that the size etched on the part and labeled on the product packaging were incorrect. Zimmer Biomet distributed recall notices on April 28, 2017, via FedEx. Customers were instructed to do the following: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1 Certificate of Acknowledgement. a. Return a digital copy to [email protected]. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to [email protected]. For further questions, please call (574) 371-3071.
Quantity in commerce: 24
Distribution: Worldwide Distribution - US Distribution to the states of: WI, CA, PA, NJ, IN, VA, WA, MN and HI ., and to the countries of : Brazil, Canada, Australia, Netherlands, Germany, Iran and Nigeria. VA/DOD: None
Product codes and lots: Item Number: 00-5988-020-14, Lot Number: 63463357, Description: NexGen Offset Stem Ext Size 14, UDI: (01)00889024221475(17)260930(10)63463357; Item Number: 00-5988-020-17, Lot Number: 63463367, Description: (01)00889024221505(17)260930(10)63463367, Manufactured Date: 9/19/2016, Expiration Date: 9/30/2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2115-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2115-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-18

Product code JWH

K933785Class IINext Generation Knee SystemZimmer, Inc. / cleared 1995-01-30

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)