RegWardenFDA facility compliance records
Recall

Class II — Encore Medical, Lp

Recalling firmENCORE MEDICAL, L.P.
Registered facilityView this company's 3 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThe labeling is missing the size/diameter information.
ProductExprt 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.
Quantity209 units
DistributionUS Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.
Initiated2015-09-16
Classified2015-10-26
Terminated2016-01-04
Recall numberZ-0165-2016
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Encore Medical, Lp (Z-0165-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72216/

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