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.
What this means for you
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 S
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 3,638
Distribution
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.
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