The Recall Desk

FDA (Devices) recall action 85637

Smith & Nephew, Inc. recalled 6 products on 2020-06-17

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2020-06-17
Critical
0
Units
15,181

Why these products were recalled

A manufacturing error resulted in out of specification R3 Acetabular Shells

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.

1–6 of 6

  • HighFDA (Devices)··2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 58 R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-06-17

    Smith & Nephew Recalls R3 Multi Hole Hemispherical Shells Due to Manufacturing Error

    Smith & Nephew is recalling 1,766 R3 Multi Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-06-17

    Smith & Nephew R3 Acetabular Shells Recalled for Manufacturing Error

    Smith & Nephew is recalling R3 No Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 4,172 R3 Acetabular Shells distributed worldwide because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 1,450 R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM…
    Category
    Distribution
    0 states