Zimmer Natural-Knee II Femoral Component Packaging Adhesion Recall
Zimmer, Inc. is recalling Natural-Knee II Femoral Components because the low-density polyethylene packaging bags adhere to the polished 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, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling 13,483 units of the Natural-Knee II Femoral Component. The recall is due to a packaging defect where 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 nationwide in the United States and in numerous countries across the Americas, Asia, Europe, and Oceania. The specific part numbers involved are 6212 and 6307-00-006/051.
Consumers and healthcare providers should contact Zimmer, Inc. for further instructions regarding the return or replacement of these specific components.
The recalled product
- Product
- Natural-Knee¿ II Femoral Component
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 13,483
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)
- Part Number Range:6212
- 6307-00-006/051
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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