The Recall Desk
ModerateFDA (Devices)·Z-2558-2017·Announced 2017-06-21

Zimmer Biomet Recalls Sterile Femoral Intramedullary Nail Implants

Zimmer Biomet is recalling sterile femoral intramedullary nail implants due to packaging design verification test failures.

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 a packaging design verification failure. As no illnesses, injuries, or specific contamination are reported in the source text, it falls under the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures.

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 involves 9,867 units of the Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories.

The action was taken because the sterile-packaged implants, which were packaged in two different configurations, failed packaging design verification tests. The affected items are identified by Item Number 00225248016 and have an expiry date before March 2027.

These products were distributed worldwide, including nationwide in the United States and in numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, and France. Healthcare providers and facilities should stop using these specific implants and contact Zimmer Biomet for instructions on return or replacement.

The recalled product

Product
Fem IM Nail 16mmdx48cm, 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:00225248016
  • 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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