Zimmer Recalls Natural-Knee II Unicompartmental Knee System Components
Zimmer, Inc. is recalling specific Natural-Knee II unicompartmental knee system tibia components due to discoloration caused by premature oxidation during storage.
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 does not report any illnesses, injuries, or hospitalizations. The hazard is a cosmetic defect (discoloration) resulting from storage conditions, which aligns with the 'Moderate' criteria for low-risk issues without reported harm.
Plain-English summary
Zimmer, Inc. is recalling 3,638 units of the Natural-Knee II Unicompartmental Knee System, specifically the UNI ALL-POLY TIB SZ 1-7mm and UNI ALL-POLY TIB SZ 1-9mm components. The affected items are identified by Item Numbers 613001007 and 613001009.
The recall was initiated after a complaint was received regarding a discolored All Poly Tibia. A root cause analysis determined that the discoloration resulted from free radical oxidation. This oxidation process was advanced prematurely because the machined components were stored in transparent containers exposed to artificial light for six years prior to inert packaging and sterilization.
The affected devices were distributed worldwide, including nationwide in the United States and in Canada, Australia, India, Austria, Japan, the Czech Republic, South Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland. Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the replacement or return of these specific components.
The recalled product
- Product
- Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 3,638
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)
- Item Number 613001007 613001009
Distribution
Part of a larger recall action
This product is one of 15 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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