NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Reported: July 9, 2014 Initiated: May 19, 2014 #Z-1936-2014
Product Description
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Reason for Recall
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 41,180 total
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.. Recalled by Zimmer, Inc.. Units affected: 41,180 total.
Why was this product recalled? ▼
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 9, 2014. Severity: Moderate. Recall number: Z-1936-2014.
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