The Recall Desk

FDA (Devices) recall action 85433

Smith & Nephew, Inc. recalled 2 products on 2020-06-03

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
2020-06-03
Critical
0
Units
395

Why these products were recalled

The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

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

  • HighFDA (Devices)··2020-06-03

    Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments

    Smith & Nephew is recalling 200 units of Journey II Uni Resection Prep Trial instruments because a manufacturing defect could cause the device to disassemble during surgery.

    Product
    JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-06-03

    Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments

    Smith & Nephew is recalling 195 reusable surgical instruments because a manufacturing defect could cause the device to disassemble during use.

    Product
    JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable
    Category
    Distribution
    0 states