The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2569-2017·Announced 2017-06-21

Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Design Failures

Zimmer Biomet is recalling 9,867 sterile knee joint implants because packaging design verification tests failed. The action affects 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 specific sterile-packaged knee joint femorotibial meta/polymer constrained cemented prostheses. The recall involves 9,867 units of the segmental fluted stem, 18x190mm str, identified by Item Number 00585205218. The affected lots have expiry dates before March 2027.

The recall was initiated because the sterile-packaged implants, which were packaged in two different 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, or where the probability of serious adverse health consequences is remote.

The affected products were distributed worldwide, including in the United States and numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, France, India, Japan, and others. Consumers and healthcare providers should check their inventory for the specific item number and lot details and contact Zimmer Biomet for further instructions on how to return or replace the affected devices.

The recalled product

Product
Segmental fluted stem, 18x190mm 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
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: 00585205218
  • 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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