The Recall Desk

FDA (Devices) recall action 78193

Encore Medical, Lp recalled 2 products on 2017-11-01

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
2017-11-01
Critical
0
Units
94

Why these products were recalled

It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.

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.

1–2 of 2

  • ModerateFDA (Devices)··2017-11-01

    Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error

    Encore Medical is recalling 46 EMPOWR PS Knee Inserts because one unit was packaged with the wrong implant. The recall covers US nationwide distribution.

    Product
    EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conf
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-11-01

    Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error

    Encore Medical is recalling 48 units of EMPOWR PS Knee inserts because one unit was packaged with the wrong implant reference number.

    Product
    EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to
    Category
    Distribution
    0 states