The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1249-2014·Announced 2014-03-26

Zimmer Recalls Natural-Knee N-K II Domed All-Poly Pat Components

Zimmer, Inc. is recalling 3,638 units of Natural-Knee N-K II Domed All-Poly Pat components due to discoloration caused by premature oxidation.

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 voluntary precautionary recall.

Plain-English summary

Zimmer, Inc. is recalling 3,638 units of Natural-Knee N-K II Domed All-Poly Pat, sizes 0 and 1. The affected components are identified by item numbers 00591101128 and 00591101137. The recall covers distribution in the United States (including DC and specific states) and in Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.

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 component was stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the affected components. The source text does not specify specific actions for consumers or report any illnesses or injuries associated with this recall.

The recalled product

Product
Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
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 00591101128 00591101137

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 →

Related recalls

Same manufacturer · Zimmer, Inc.

See all →

Same hazard · material degradation

See all →

Similar recalls