The Recall Desk

FDA (Devices) recall action 76943

Smith & Nephew, Inc. recalled 12 products on 2017-05-10

The FDA (Devices) publishes a recall like this one as 12 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 12 pages.

Products
12
Announced
2017-05-10
Critical
0
Units
37,373

Why these products were recalled

The stability data does not support the product labeled with a 10-year shelf life.

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

1–12 of 12

  • ModerateFDA (Devices)··2017-05-10

    Smith & Nephew Recalls Radial Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling 1,126 units of Renovation Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2017-05-10

    Smith & Nephew Recalls Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling 1,741 units of Renovation osteotome blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1)
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2017-05-10

    Smith & Nephew Recalls Radial Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling 1,416 units of Renovation Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2017-05-10

    Smith & Nephew Recalls Radial Osteotome Blades Due to Stability Data

    Smith & Nephew is recalling specific lots of Renovation Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
    Category
    Distribution
    1 state