The Recall Desk
ModerateFDA (Devices)·Z-2562-2017·Announced 2017-06-21

Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures

Zimmer Biomet is recalling sterile femoral intramedullary nails because packaging design verification tests failed. The action affects 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 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 sterile-packaged femoral intramedullary nails. The specific product involved is the Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories. The recall was triggered by packaging design verification test failures for implants packaged in two different configurations.

The affected units are identified by Item Number 00225748004 and have an expiry date before March 2027. A total of 9,867 units were distributed. The distribution pattern includes the United States (nationwide) and numerous foreign countries, including Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, India, Italy, Japan, and others.

This is a Class II recall, which indicates 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. Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the field action.

The recalled product

Product
Fem IM Nail 14mmdx48cm left, 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:00225748004
  • 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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