Agency classClass IIOur severity:High FDA (Devices)·Z-2584-2014·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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves corrosion of a surgical instrument used in orthopedic procedures, which poses a risk of harm even though specific injuries are not detailed in the source text.

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 6290-00-703. The recall covers 8,638 distribution events and includes lots manufactured by both Zimmer and Centerpulse. The products were distributed worldwide, including in the United States and in Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.

This is a Class II recall, which means the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Users should contact Zimmer, Inc. for further instructions regarding the return or replacement of the affected instruments.

The recalled product

Product: Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. 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: 6290-00-703. Lots Manufactured by Zimmer: 1324204
1346689
1361954
1371127
1374460
1382191
1386076
1388163
1421648
1440890
1441119
1476227
1476229
1493832
1493841
1516853
1530324
1549264
1549388
1554288

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