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 Empowr PS Insert was reported as missing the impaction slot feature.
ProductEmpowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
Quantity24 units
DistributionNationwide Distribution to CO, NY, and FL
Initiated2017-01-10
Classified2017-02-03
Terminated2017-05-11
Recall numberZ-1139-2017
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-1139-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76206/

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