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Recall Observatory FDA recall evidence

Device product

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.

Z-1938-2014

May 19, 2014

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 68457
Status
Terminated
Classification
Class II
Quantity
41,180 total
Official record key
device-enforcement:Z-1938-2014

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 7, includes the following Lot Numbers: 370320 37214653 61424998 61442326 61459971 61459972 61488229 61518205 61543979 61658887 61658888 61827120 61827121 61827122 61979040 61979041 62051526 62091729 62200288 62227423 62251572 62330688 62383359 62383362 62401016 62401017 62602812 62602813 62640983

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

    reason.potency_specification_failure · v1.0.0

    out of specification