Zimmer Recalls Natural-Knee II Poly Ultra Tibia Components Due to Discoloration
Zimmer, Inc. is recalling 3,638 Natural-Knee II Poly Ultra Tibia components worldwide 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 quality defect (discoloration/oxidation) without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer, Inc. is recalling 3,638 units of the Natural-Knee II System, specifically the Poly Ultra Tibia components, due to a quality issue. The affected items were distributed nationwide in the United States and in several international countries, including Canada, Australia, India, and various European nations.
The recall was initiated after a complaint was received regarding a discolored All Poly Tibia. Root cause analysis determined that the discoloration was the result of 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 source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any illnesses or injuries associated with the use of these components.
The recalled product
- Product
- Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1 ALL POLY ULTRA TIB RT SZ1 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB LT SZ2 ALL POLY…
- 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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