Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1259-2014·Announced 2014-03-26

Zimmer Recalls Apollo Knee Tibial Baseplates Due to Discoloration

Zimmer, Inc. is recalling 3,638 Apollo Knee Tibial Baseplates and Inserts because free radical oxidation caused discoloration in some units.

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 involving minor defects or low-risk issues.

Plain-English summary

Zimmer, Inc. is recalling 3,638 units of Apollo Knee Tibial Baseplates and Knee 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 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 in several international countries including Canada, Australia, India, Austria, Japan, the Czech Republic, South Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland. Consumers and healthcare providers should contact Zimmer, Inc. for further instructions regarding the affected units.

The recalled product

Product: Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG 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