Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1258-2014·Announced 2014-03-26

Zimmer Recalls Apollo Knee System Patella Components Due to Discoloration

Zimmer, Inc. is recalling 3,638 units of Apollo Knee System patella components 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 describes a cosmetic defect (discoloration) resulting from storage conditions without reporting any injuries, illnesses, or functional failures, aligning with the 'Moderate' criteria for minor issues or voluntary precautionary actions.

Plain-English summary

Zimmer, Inc. is recalling 3,638 units of the Apollo Knee System, specifically the APOLLO PATELLA SZ0 28MM R (Item Number 680001000). 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 nationwide in the United States, including DC and various states, as well as in Canada, Australia, India, Austria, Japan, the 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: Apollo" Knee System: APOLLO PATELLA SZ0 28MM R
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: discoloration
oxidation
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 680001000

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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Same hazard · discoloration