The Recall Desk
ModerateFDA (Devices)·Z-2553-2017·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 action affects 9,867 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, but the source text attributes the action to packaging design verification test failures without reporting any illnesses, injuries, or specific contamination hazards, fitting the criteria for a moderate severity precautionary action.

Plain-English summary

Zimmer Biomet, Inc. has initiated a field action for sterile-packaged femoral intramedullary nail implants and specific knee, hip, and nail accessories. The recall was triggered by packaging design verification test failures for implants packaged in two different configurations.

The affected product is the Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary. The recall covers 9,867 units with Item Number 00225244015 and an expiry date before March 2027. These products were distributed nationwide in the United States and in numerous foreign countries, including Argentina, Australia, Belgium, Brazil, Canada, France, India, Japan, and others.

This is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences. Healthcare providers and facilities should check their inventory for the specific item number and lot dates mentioned in the recall notice and contact Zimmer Biomet for instructions on how to proceed.

The recalled product

Product
Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- 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: 00225244015
  • 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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