Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile knee joint implants because packaging design verification tests failed. The action affects 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 packaging design verification test failures. There are no reports of illness, injury, or death, and the hazard is related to packaging integrity rather than a direct product defect causing harm.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged knee joint femorotibial meta/polymer constrained cemented prosthesis implants. The recall involves 9,867 units of the segmental fluted stem (17x250mm bwd) that were packaged in two different configurations.
The field action was taken due to packaging design verification test failures. The affected products are sterile implants intended for use in knee joint procedures.
The products were distributed nationwide in the United States and to foreign countries including Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, India, Italy, Japan, and others. Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to handle the affected devices.
The recalled product
- Product
- Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
- 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: 00585205417
- Lot Number Expiry Date Before: September 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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