Zimmer Biomet Recalls Sterile Porous Femoral Stems Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile porous femoral stems because packaging design verification tests failed. The recall covers units distributed worldwide.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential loss of sterility due to packaging failure, which fits the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. has initiated a field action for sterile-packaged porous fully coated femoral stems (16x200mm). The recall involves 9,867 units with item number 00784301608 and expiry dates before July 2026.
The action was taken because the implants were packaged in two different configurations that failed packaging design verification tests. These tests are designed to ensure the packaging maintains the sterility and integrity of the medical device.
The affected products were distributed nationwide in the United States and to numerous foreign countries, including Argentina, Australia, Belgium, Brazil, Canada, and others. Healthcare providers and facilities that have received these specific lots should stop using them and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Por fullct fem st 16x200mm, Sterile,
- Manufacturer
- Zimmer Biomet, Inc.
- 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: 00784301608
- 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.
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