Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile knee implants due to packaging design verification test failures. The field action affects 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, but the source text explicitly attributes the issue to packaging design verification test failures without reporting any illnesses, injuries, or confirmed sterility breaches. This aligns with the rubric for voluntary precautionary recalls or low-risk contamination where harm has not been reported.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged implants. The specific product involved is the Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis. The recall covers 9,867 units.
The reason for the field action is packaging design verification test failures. The source text does not specify the exact nature of the packaging defect or any resulting contamination or sterility breach.
The affected units were distributed worldwide, including the United States and numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, India, Italy, Japan, and others. The source text does not provide specific lot numbers or expiration dates beyond a general indication that expiry dates are before March 2027. Consumers and healthcare providers should contact Zimmer Biomet for further instructions on handling these specific implants.
The recalled product
- Product
- Segmental malefemale taper, 220mm, 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: 00585004622
- Lot Number Expiry Date Before: March 2027
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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