The Recall Desk

FDA (Devices) recall action 79115

DePuy Orthopaedics, Inc. recalled 2 products on 2018-03-07

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
2018-03-07
Critical
0
Units
23,053

Why these products were recalled

The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.

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)··2018-03-07

    DePuy Orthopaedics Recalls DELTA XTEND Reverse Shoulder System Implants

    DePuy Orthopaedics is recalling 23,053 DELTA XTEND Reverse Shoulder System implants because the epiphysis may not assemble to the stem, potentially causing surgical delays.

    Product
    DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-03-07

    DePuy Orthopaedics Recalls DELTA XTEND Reverse Shoulder System Implants

    DePuy Orthopaedics is recalling DELTA XTEND Reverse Shoulder System implants because the epiphysis may not assemble to the stem, potentially causing surgical delays.

    Product
    DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
    Category
    Distribution
    0 states