Zimmer Recalls Natural-Knee II System Components Due to Discoloration
Zimmer, Inc. is recalling 3,638 units of Natural-Knee II System components due to discoloration caused by premature oxidation. The affected devices were stored in transparent containers exposed to light.
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. The hazard involves discoloration due to oxidation, which is a quality defect without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Zimmer, Inc. is recalling 3,638 units of the Natural-Knee II System, including various ultra congruent inserts, rotating platform inserts, and poly congruent tibial components. The recall was initiated after a complaint was received regarding a discolored All Poly Tibia component.
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 nationwide in the United States, including DC and specific states, as well as in Canada, Australia, India, Austria, Japan, the Czech Republic, South Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland. Consumers and healthcare providers should stop using the affected components and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT SZA/11M ULTRA CONG INS RT SZA/13M ULTRA CONG INS RT SZA/19M ULTRA CONG INS LT SZB/13M ULTRA CONG INS LT SZB/16M ULTRA CONG…
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 3,638
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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