Zimmer Recalls Apollo Revision Knee System Tibia Inserts Due to Discoloration
Zimmer, Inc. is recalling 3,638 Apollo Revision/Constrained Knee System tibia inserts because they were discolored due to premature oxidation during storage.
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, but the source text describes a cosmetic defect (discoloration) caused by storage conditions without reporting any adverse health consequences, injuries, or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling 3,638 units of the Apollo Revision/Constrained Knee System tibia inserts. The affected items are identified by specific item numbers ranging from 682000016 to 682005011. These devices were 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 insert. A 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 before being placed in inert packaging and sterilized.
The source text does not specify instructions for consumers or patients regarding the immediate handling of these devices. As this is a medical device recall, patients who have had these implants should consult their healthcare providers for guidance on whether any action is required.
The recalled product
- Product
- Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB INSER SZ1-30MM AK CCK TIB INSER SZ2-11MM AK CCK TIB INSER SZ2-13MM AK CCK TIB INSER SZ2-16MM AK CCK TIB INSER SZ2-22MM AK CCK TIB I
- 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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