Device product
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Z-1939-2014
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 68457
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41,180 total
- Official record key
device-enforcement:Z-1939-2014
Official wording
Reason: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Code information: Size 8, includes the following Lot numbers: 370321 37213648 37216196 61424999 61543980 62029931 62390069
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
Derived failure modes
-
Potency or specification failure
out of specification