Zimmer Biomet Recalls Segmental Fluted Stems Due to Packaging Failures
Zimmer Biomet is recalling sterile segmental fluted stems because packaging design verification tests failed. The recall covers 9,867 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 and involves a packaging defect 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 segmental fluted stems (18x250mm bwd). The recall involves 9,867 units of the implant, identified by Item Number 00585205418, with lot numbers expiring before July 2026.
The recall was initiated because the sterile packaging failed design verification tests. The affected products were distributed nationwide in the United States and in numerous foreign countries, including Argentina, Australia, Belgium, Brazil, Canada, France, India, Italy, Japan, and others.
Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these specific implants. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Segmental fluted stem, 18x250mm bwd, Sterile,
- Manufacturer
- Zimmer Biomet, Inc.
- 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: 00585205418
- 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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