The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2568-2017·Announced 2017-06-21

Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Design Failures

Zimmer Biomet is recalling sterile knee joint femorotibial implants because packaging design verification tests failed. The recall 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, which typically corresponds to a Moderate severity score (2) when no specific injuries or illnesses are reported, as the hazard is related to packaging verification rather than a direct biological or mechanical defect causing immediate harm.

Plain-English summary

Zimmer Biomet, Inc. has initiated a field action for sterile-packaged knee joint femorotibial meta/polymer constrained cemented prosthesis implants. The specific product involved is the Segmental fluted stem, 17x190mm str, sterile, identified by Item Number 00585205217. The recall covers 9,867 units with lot numbers expiring before March 2027.

The recall was initiated on February 28, 2017, due to packaging design verification test failures. The implants were packaged in two different package configurations that did not meet the required verification standards. 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 check their inventory for the specific item number and expiration date range. If the product is found, it should be removed from use and returned to the manufacturer or an authorized representative.

The recalled product

Product
Segmental fluted stem, 17x190mm 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: 00585205217
  • 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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