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
ReasonProduct mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
ProductAltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
Quantity15
DistributionUS Nationwide distribution.
Initiated2020-08-31
Classified2020-10-16
Terminated2024-04-19
Recall numberZ-0117-2021
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-0117-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86395/

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