The Recall Desk
ModerateFDA (Devices)·Z-1255-2014·Announced 2014-03-26

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.

What this means for you

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 I
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
3,638

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically:

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.

See all 15 products in this recall →

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