The Recall Desk
ModerateFDA (Devices)·Z-2557-2017·Announced 2017-06-21

Zimmer Biomet Recalls Sterile Intramedullary Nail Implants Due to Packaging Failures

Zimmer Biomet is recalling sterile intramedullary nail implants because packaging design verification tests failed. The recall covers specific lots 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 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 Fem IM Nail 15mmdx48cm implants and specific knee, hip, and nail accessories. The recall is due to packaging design verification test failures for implants packaged in two different configurations.

The affected product is identified by Item Number 00225248015 and includes lots with expiry dates before March 2027. The distribution pattern is worldwide, including the United States and numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, and others.

This is a Class II recall. Consumers and healthcare providers should check their inventory for the specific item number and lot dates mentioned. If the product is found, it should be removed from use and returned to the manufacturer or a designated facility according to the recall instructions.

The recalled product

Product
Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard

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:00225248015
  • 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 →

Related recalls

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · packaging failure

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