Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
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 is a voluntary precautionary recall based on a potential manufacturing defect (threads out of specification) without reported injuries or illnesses.
Plain-English summary
Zimmer, Inc. is initiating a voluntary recall of specific identified lots of the NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. This product is part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
The recall is being conducted due to the potential that the threads on the components may be out of specification. A total of 41,180 units are affected by this recall.
The affected products were distributed nationwide in the United States and internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan. The specific lot numbers involved are listed in the official recall documentation.
The recalled product
- Product
- NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 41,180
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)
- Size 4
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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