Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2582-2014·Announced 2014-09-10

Zimmer Recalls Natural-Knee Patella Bushings Due to Corrosion Complaints

Zimmer, Inc. is recalling Natural-Knee System Patella Bushings due to a trend of complaints indicating product corrosion. The affected orthopedic surgical instruments were distributed worldwide.

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. The source text cites a trend of complaints regarding corrosion but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving a potential defect without confirmed harm.

Plain-English summary

Zimmer, Inc. is recalling the Natural-Knee System Patella Bushings, an orthopedic surgical instrument used as a guide for the matching size 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 6290-00-690. 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 specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the corrosion.

The recalled product

Product: Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. 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…
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 6290-00-690. Lots Manufactured by Zimmer: 1327524
1339783
1344879
1346702
1361955
1368604
1382204
1386058
1388164
1429297
1437553
1441291
1441897
1451867
1465171
1470848
1470849
1472371
1516851
1530342

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