Zimmer Biomet Recalls Sterile Intramedullary Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
What this means for you
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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is limited to packaging verification failures without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged implants. The specific products involved are segmental fluted stems, 19x250mm bwd, sterile, rod fixation intramedullary and accessories, specifically for knee, hip, and nail implants. The recall was triggered by packaging design verification test failures for implants packaged in two different package configurations.
A total of 9,867 units are affected by this action. The products were distributed nationwide in the United States and internationally to numerous countries, including Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, India, Italy, Japan, and others. The affected items are identified by Item Number 00585205419 and have an expiry date before July 2026.
Consumers and healthcare providers should check their inventory for these specific sterile implants. If the products match the description and item number provided, they should stop using them and contact Zimmer Biomet for further instructions regarding the field action.
The recalled product
- Product
- Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- 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: 00585205419
- 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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