Z-2092-2023Class II

NexGen Precoat Stemmed Tibial Plate Size 5

Name: Z-2092-2023 NexGen Precoat Stemmed Tibial Plate Size 5
Creator: Zimmer, Inc.
Published: 2023-05-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2023-05-19 / Terminated / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of NexGen Precoat Stemmed Tibial Plate Size 5 on 2023-05-19. FDA classified it as Class II and gives the reason as "Device outer packaging was incorrectly labeled". 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-2092-2023
Classification: Class II
Status: Terminated
Initiated: 2023-05-19
Posted: 2023-07-05
Terminated: 2026-05-29
Recalling firm: Zimmer GmbH
Product: NexGen Precoat Stemmed Tibial Plate Size 5
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Device outer packaging was incorrectly labeled.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm distributed recall notifications by email on 5/19/2023. Customers are asked to review the recall notification and distribute to team members so they are aware of its contents. Additionally, customers are to identify and quarantine any affected devices, complete the provided Inventory Return Certification form, and ship affected product back to Zimmer. Customers are to retain a copy of the Inventory Return Certification for their records. Customers with any questions may call 574-371-3071 or email [email protected].
Distribution: International distribution in the country of India.
Product codes and lots: Model No. 00598004701; UDI No./Lot. No.: (01)00889024217607(17)321228(10)J7418537/J7418537 and (01)00889024217607(17)321228(10)J7418542/J7418542.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2092-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2092-2023	Class II	Terminated	Voluntary: Firm initiated	2023-07-12	2023-07-05

Product code JWH

K173057Class IIZimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. / cleared 2018-03-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)