Z-0449-2016Class II

Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial...

Name: Z-0449-2016 Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial...
Creator: Zimmer Manufacturing B.V.
Published: 2015-12-02
License: https://open.fda.gov/license/

Zimmer Manufacturing B.V. / initiated 2015-12-02 / Terminated / root cause: packaging

FDA source

Zimmer Manufacturing B.V. began a recall of Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264... on 2015-12-02. FDA classified it as Class II and gives the reason as "Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0449-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-02
Posted: 2015-12-18
Terminated: 2016-09-16
Recalling firm: Zimmer Manufacturing B.V.
Product: Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264
Root cause tag: packaging
FDA root cause: Packaging
Action: An Urgent Medical Device Recall Letter, dated 12/2/15, was sent to the firm's consignees. All distributors will be notified via electronic mail. Hospital risk managers, surgeons, and distributors with product will be notified via courier.
Quantity in commerce: 179
Distribution: US Distribution and the country of Thailand.
Product codes and lots: lot #62460264

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0449-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0449-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-18

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)