Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2585-2014·Announced 2014-09-10

Zimmer Recalls Natural-Knee System Patella Bushings Due to Corrosion

Zimmer, Inc. is recalling Natural-Knee System Patella Bushings because of a trend of complaints indicating product corrosion.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths, nor does it identify a high-risk pathogen or structural defect causing immediate harm, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer, Inc. is recalling the Natural-Knee System Patella Bushings, an orthopedic surgical instrument used as a guide for the patella cutter. The recall is being conducted due to a trend of complaints indicating corrosion of the product.

The affected product is identified by Part Number 6290-00-704. The recall covers 8,638 distribution events. Distribution was worldwide, including the United States and the countries of Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.

The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items, nor does it report any specific injuries or illnesses associated with the corrosion.

The recalled product

Product: Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Surgical Instrument
Hazard: corrosion
Affected units: 8,638

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Part Number 6290-00-704. Lots Manufactured by Zimmer: 1137602
1324205
1331331
1346218
1351208
1368598
1373552
1376006
1382199
1386059
1422626
1426895
1438006
1441899
1475757
1475758
1478938
1493445
1517176
1525953

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Zimmer, Inc.

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Same hazard · corrosion