Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2582-2017·Announced 2017-06-21

Zimmer Biomet Recalls Sterile Intramedullary Rod Implants Due to Packaging Failures

Zimmer Biomet is recalling sterile intramedullary rod implants and accessories 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 due to packaging design verification test failures. As no illnesses or injuries are reported and the hazard is related to packaging integrity rather than a direct defect in the implant material itself, it fits 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, specifically the XL POR ST 24.0x220mm, bowed, sterile rod fixation intramedullary and accessories for specific knee, hip, and nail implants. The recall was triggered by packaging design verification test failures for sterile-packaged implants packaged in two different package configurations.

The recall involves 9,867 units of the product, identified by Item Number 00992124033, with lot numbers expiring before March 2027. These products were distributed nationwide in the United States and to foreign countries including Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, India, Italy, Japan, and many others.

Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these specific sterile implants. The FDA has classified this as a Class II recall.

The recalled product

Product: Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- 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: 00992124033
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