The Recall Desk

FDA (Devices) recall action 93623

Encore Medical, LP recalled 2 products on 2024-01-10

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-01-10
Critical
0
Units
19

Why these products were recalled

Mislabeling

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2024-01-10

    Patella implant component recalled due to labeling error

    Encore Medical has voluntarily recalled a patella implant component (REF 130-03-738) due to mislabeling. The recall involves 2 units distributed nationwide.

    Product
    REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2024-01-10

    Reverse Shoulder Joint Implant System Recalled for Mislabeling

    Encore Medical is recalling 17 Reverse Shoulder System e+ surgical implants (Lot 381P1167) due to mislabeling. Affected units were distributed nationwide to multiple states.

    Product
    Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
    Category
    Distribution
    11 states