The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2549-2017·Announced 2017-06-21

Zimmer Biomet Recalls Sterile Intramedullary Femoral Stems Due to Packaging Failures

Zimmer Biomet is recalling sterile intramedullary femoral stems and accessories due to packaging design verification test failures.

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 packaging verification 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 implants. The specific products involved are Por fullct fem st 20x200mm, sterile rod fixation intramedullary and accessories, specifically for knee, hip, and nail implants. The recall covers 9,867 units.

The reason for this field action is packaging design verification test failures. The source text indicates that the implants were packaged in two different package configurations that failed these tests. The agency classification for this recall is Class II.

The products were distributed worldwide, including nationwide in the United States and in numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, and others. The affected item number is 00784302008, with lot numbers expiring before July 2026. Healthcare providers and facilities should contact Zimmer Biomet for instructions on how to handle these specific sterile implants.

The recalled product

Product
Por fullct fem st 20x200mm, 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: 00784302008
  • Lot Number Expiry Date Before: July 2026

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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