The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1257-2014·Announced 2014-03-26

Zimmer Recalls Natural-Knee II Tibial Inserts Due to Discoloration

Zimmer, Inc. is recalling 3,638 Natural-Knee II Posterior Stabilized Condylar Tibial Inserts because free radical oxidation caused discoloration.

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, and the hazard involves a cosmetic defect (discoloration) resulting from storage conditions, which aligns with the criteria for moderate severity.

Plain-English summary

Zimmer, Inc. is recalling 3,638 units of Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Inserts. The recall was initiated after a complaint was received regarding a discolored All Poly Tibia component.

Root cause analysis determined that the discoloration was the result of free radical oxidation. This oxidation process was advanced prematurely because the machined component was stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

The affected units were distributed worldwide, including nationwide in the United States and in Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland. Consumers and healthcare providers should contact Zimmer, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product
Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS…
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implants
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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