The Recall Desk

FDA (Devices) recall action 72655

Smith & Nephew, Inc. recalled 2 products on 2015-12-16

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
2015-12-16
Critical
0
Units
18

Why these products were recalled

The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.

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)··2015-12-16

    Smith & Nephew Recalls Anatomically Incorrect Volar Distal Radius Plates

    Smith & Nephew is recalling 9 units of PERI-LOC Volar Distal Radius Plates that were laser marked and packaged with incorrect anatomical orientation.

    Product
    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-12-16

    Smith & Nephew Volar Distal Radius Plates Recalled for Incorrect Marking

    Smith & Nephew is recalling 9 units of PERI-LOC VOLAR DISTAL RADIUS PLATES because they were laser marked and packaged with incorrect anatomical orientation.

    Product
    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate
    Category
    Distribution
    0 states