Zimmer Natural-Knee II System Modular Cemented Tibial… recallZ-1482-2009 · Zimmer Inc. · initiated Mar 18, 2009

Terminated All recalls posted in June 2009

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Zimmer Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The tibial spacer will not affix to the distal surface of the baseplate, as intended.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number: Z-1482-2009
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: Mar 18, 2009
Posted by the FDA: Jun 30, 2009
Recalling firm: Zimmer Inc.
Quantity: 834 of all products
Product code: JWH
FDA submissions: K023528
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 description

Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 00, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-00-002. 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.

Code information (models, lots, serial numbers)

All lots.

Other devices under the same FDA submission

1 device cleared under K023528 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Natural-Knee® 6420-00-210
Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 51406).

Z-1483-2009 · Terminated
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 00, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-002. The Natural-Knee II…
Z-1484-2009 · Terminated
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…
Z-1485-2009 · Terminated
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-200. The Natura…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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