Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer 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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential manufacturing defect (threads out of specification) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
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 1. 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. The products were distributed nationwide in the United States and internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
The affected lots include the following numbers: 37217848, 61424993, 61507222, 61543969, 61774117, 62141262, 62193298, 62251564, 62261955, 62383353, 62602809, 62602810, and 62602811. Healthcare providers and facilities should check their inventory for these specific lot numbers and contact Zimmer for further instructions.
The recalled product
- Product
- NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. 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 1
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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