Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1260-2014·Announced 2014-03-26

Zimmer Recalls Apollo Knee System Tibia Inserts Due to Discoloration

Zimmer, Inc. is recalling 3,638 Apollo Knee System tibia inserts because free radical oxidation caused discoloration. The issue resulted from improper storage conditions prior to packaging.

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 is 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 the Apollo Knee System, specifically the PS Tibia Inserts in various sizes. The recall covers units 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 caused by 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 before being placed in inert packaging and sterilized.

The source text does not specify instructions for consumers or patients regarding the recalled devices. As this is a medical device recall, patients with implanted devices should consult their healthcare providers for guidance on any necessary actions.

The recalled product

Product: Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2/16M APOLLO PS TIB INS SZ2/22MM APOLL PS TIB INS SZ3/16MM APOLL PS TIB INS SZ3/19MM APOLL PS TIB INS SZ4/9MM APOLLO PS TIB INS…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: discoloration
oxidation
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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Same hazard · discoloration