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Recall Observatory FDA recall evidence

Device product

Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

Z-0165-2016

September 16, 2015

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 72216
Status
Terminated
Classification
Class II
Quantity
209 units
Official record key
device-enforcement:Z-0165-2016

Official wording

Reason: The labeling is missing the size/diameter information.

Code information: 471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008

Distribution pattern: US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling is missing