Z-1484-2009

Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 0, TIB B/PL, for cemented use...

Name: Z-1484-2009 Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 0, TIB B/PL, for cemented use...
Creator: Zimmer Inc.
Published: 2009-03-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-03-18 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number... on 2009-03-18. The reason FDA records is "The tibial spacer will not affix to the distal surface of the baseplate, as intended". 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-1484-2009
Status: Terminated
Initiated: 2009-03-18
Posted: 2009-06-30
Terminated: 2009-10-23
Recalling firm: Zimmer GmbH
Product: Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-00-200. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The tibial spacer will not affix to the distal surface of the baseplate, as intended.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Zimmer, Inc. issued an "Urgent-Device Recall" letter dated March 18, 2009 instructing users to cease using and return the affected product accompanied with a completed Inventory Return Certification form. The inventory Return Certification form should also be faxed to Zimmer, Inc. at 1-574-372-4265. Further questions should be addressed to Zimmer, Inc. at 1-800-613-6131.
Quantity in commerce: 834 of all products
Distribution: Worldwide Distribution - USA including states of CA, NY, MI, OH, WI, IA, MN, NJ, IL, MO, TX, LA, NC, SC, PA, AR, MS, FL, GA, AL, OK, KS, TN, CT, NM, UT, NV, ID and CO and Switzerland.
Product codes and lots: All lots.

Product code JWH

K023528Class IINatural-Knee II Cemented Modular Tibial BaseplateCenterplus Orthopedics, Inc. / cleared 2003-01-17

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)