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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 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.

Z-1931-2014

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-1931-2014

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 1, includes the following Lot numbers: 37217848 61424993 61507222 61543969 61774117 62141262 62193298 62251564 62261955 62383353 62602809 62602810 62602811

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