The Recall Desk
ModerateFDA (Devices)·Z-2571-2017·Announced 2017-06-21

Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Failures

Zimmer Biomet is recalling 9,867 sterile knee implants because packaging design verification tests failed. The devices were distributed worldwide.

What this means for you

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 illnesses or injuries, 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 implants. The specific product involved is the Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis. The recall covers 9,867 units with Item Number 00585205415 and an expiry date before March 2027.

The reason for the recall is that the sterile-packaged implants, which were packaged in two different package configurations, failed packaging design verification tests. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected products were distributed worldwide, including in 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 the recalled devices.

The recalled product

Product
Segmental fluted stem, 15x250mm bwd, 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
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: 00585205415
  • 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 →

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