Zimmer Biomet Recalls Sterile Hip Implants Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile hip implants because packaging design verification tests failed. The recall covers 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, and the source text identifies the cause as packaging design verification test failures without reporting any illnesses or injuries. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary actions where harm is not yet reported.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for specific sterile-packaged hip implants. The affected products are segmental VSS bowed 19x190mm hip joint prostheses, described as metal/ceramic/polymer, semi-constrained, and cemented or nonporous uncemented. The recall involves 9,867 units.
The reason for the recall is that the sterile-packaged implants, which were packaged in two different configurations, failed packaging design verification tests. This is a Class II recall, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences.
The affected products were distributed worldwide, including in the United States and numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, and others. The specific item number is 00585207419, and the lot numbers have expiry dates before March 2027. Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the field action.
The recalled product
- Product
- Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants
- 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: 00585207419
- 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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