Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2570-2017·Announced 2017-06-21

Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Test Failures

Zimmer Biomet is recalling sterile knee implants because packaging design verification tests failed. The action affects 9,867 units 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 and involves packaging design verification test failures without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged knee joint femorotibial meta/polymer constrained cemented prosthesis implants. The specific product involved is the Segmental fluted stem, 19x190mm str, sterile, with item number 00585205219 and lot numbers expiring before March 2027.

The recall was initiated due to packaging design verification test failures. The source text does not specify the exact nature of the packaging defect or any resulting clinical harm, but the failure occurred in the sterile packaging configuration.

A total of 9,867 units were distributed worldwide, including the United States and numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, and others. Consumers and healthcare providers should contact Zimmer Biomet for further instructions on how to handle these specific implants.

The recalled product

Product: Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: packaging-failure
sterility-compromise
Affected units: 9,867

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 (2)

Item Number: 00585205219
Lot Number Expiry Date Before: March 2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 35 recalled by Zimmer Biomet, 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 35 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · packaging failure