Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2552-2017·Announced 2017-06-21

Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures

Zimmer Biomet is recalling sterile femoral intramedullary nails and accessories because packaging design verification tests failed.

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 and involves a packaging design verification failure. There are no reports of illness, injury, or death, and the hazard is related to potential loss of sterility rather than a direct structural defect or high-risk pathogen.

Plain-English summary

Zimmer Biomet, Inc. has initiated a field action for sterile-packaged femoral intramedullary nails and specific knee, hip, and nail implant accessories. The recall involves 9,867 units of the Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories.

The action was taken because the sterile packaging failed design verification tests. The affected products were distributed worldwide, including in the United States and numerous foreign countries such as Argentina, Australia, Canada, France, and Japan. The specific item number is 00225242016, and the lot numbers have expiry dates before March 2027.

Healthcare providers and facilities should stop using these specific sterile implants and contact Zimmer Biomet for instructions on return or replacement. Patients who have already received these implants should consult their healthcare provider for guidance.

The recalled product

Product: Fem IM Nail 16mmdx42cm, 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: 00225242016
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