The Recall Desk
ModerateFDA (Devices)·Z-2572-2017·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 recall covers units 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. The hazard is a packaging design verification failure, which is a potential risk to sterility but does not involve reported injuries or deaths, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary actions.

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, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis. The recall affects 9,867 units with Item Number 00585205416 and an expiry date before July 2026.

The reason for the recall is packaging design verification test failures. The source text indicates that the sterile-packaged implants were packaged in two different package configurations that did not pass these verification tests. This is a Class II recall, which indicates a situation that could temporarily cause serious adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected units were distributed worldwide, including the United States and numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, India, Italy, Japan, and others. Consumers and healthcare providers should check their inventory for the specific item number and expiry date mentioned above. If the product is found, it should be removed from use and returned to the manufacturer or a designated facility as per the recall instructions.

The recalled product

Product
Segmental fluted stem, 16x250mm 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: 00585205416
  • Lot Number Expiry Date Before: July 2026

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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