Z-1447-04

Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 2...

Name: Z-1447-04 Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 2...
Creator: Zimmer Inc.
Published: 2004-08-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2004-08-03 / Terminated

FDA source

Zimmer Inc. began a recall of Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 2, sterile, for cemented use only; Cat. No... on 2004-08-03. The reason FDA records is "The polyethylene tibial bushing was omitted from the taper of the tibial plates". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1447-04
Status: Terminated
Initiated: 2004-08-03
Posted: 2004-09-14
Terminated: 2004-09-13
Recalling firm: Zimmer GmbH
Product: Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 2, sterile, for cemented use only; Cat. No. 5880-02-02.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: The polyethylene tibial bushing was omitted from the taper of the tibial plates.
FDA root cause: Other
Action: Consignees were notified via recall letter dated August 3, 2004 and sent via certified mail, return receipt requested. A dear doctor letter dated August 25, 2004 was sent to the implanting physicians.
Distribution: Nationwide (California, Florida, Illinois, Indiana, Louisiana, Michigan, Nevada, New Jersey, New York, North Carolina, Ohio, Texas, Wisconsin), and Germany.
Product codes and lots: Lot 60037871; Exp. June 2008.

Product code KRO

K013385Class IINexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc. / cleared 2002-01-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)