Zimmer Unicompartmental Knee Femoral Component Packaging Recall
Zimmer, Inc. is recalling knee implant 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 injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling the Zimmer Unicompartmental Knee Femoral Component. This medical device is indicated for patients with painful and/or disabling knee joint conditions.
The recall is due to a packaging defect where the low density polyethylene (LDPE) bag used to package the implants adheres to the highly polished surface of the devices. This issue affects 32,537 units with part numbers in the range 00-5842-011/017-01/02.
The affected products were distributed worldwide, including the United States and numerous international markets such as Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, and others. Consumers and healthcare providers should contact Zimmer, Inc. for further instructions regarding the return or replacement of these specific components.
The recalled product
- Product
- Zimmer¿ Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint.
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 32,537
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:00-5842-011/017-01/02
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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