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
StatusOngoing
ReasonKnee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
ProductEMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Quantity9
DistributionUS Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.
Initiated2024-12-10
Classified2024-12-23
Recall numberZ-0761-2025
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-0761-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95882/

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