Zimmer Recalls Gender Solutions Patello-Femoral Components Due to Packaging Defect
Zimmer, Inc. is recalling 5,103 Gender Solutions Patello-Femoral Components because the packaging bags adhere to the device surfaces.
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, but the source text describes a packaging adhesion issue without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary actions where harm has not been reported.
Plain-English summary
Zimmer, Inc. is recalling 5,103 units of the Gender Solutions Patello-Femoral Component. The recall was initiated because the low density polyethylene (LDPE) bags used to package the implants adhere to the highly polished surface of the devices.
The affected devices were distributed worldwide, including in the United States and numerous international locations such as Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, and Mexico. The specific part numbers involved in this recall range from 00-5926-011/015-01/02.
Healthcare providers and facilities should stop using these components and contact Zimmer, Inc. for instructions on how to return the affected products. The source text does not report any illnesses or injuries associated with this packaging issue.
The recalled product
- Product
- Gender Solutions" Patello-Femoral Component
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 5,103
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 (1)
- Part Number Range:00-5926-011/015-01/02
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Zimmer, 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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