The Recall Desk

FDA (Devices) recall action 71330

Smith & Nephew, Inc. recalled 5 products on 2015-06-17

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2015-06-17
Critical
0
Units
101

Why these products were recalled

The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.

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

1–5 of 5

  • HighFDA (Devices)··2015-06-17

    Smith & Nephew R3 Constrained Liner Recalled for Sizing Defect

    Smith & Nephew is recalling 12 units of R3 Constrained Liners because the locking groove is oversized, which may prevent the locking ring from engaging properly.

    Product
    R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision…
    Category
    Distribution
    11 states
  • SevereFDA (Devices)··2015-06-17

    Smith & Nephew R3 Constrained Liner Recalled for Locking Groove Defect

    Smith & Nephew is recalling 40 units of R3 Constrained Liners because the locking groove is oversized, preventing the locking ring from engaging properly.

    Product
    R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision…
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2015-06-17

    Smith & Nephew Recalls R3 Constrained Liner Due to Sizing Defect

    Smith & Nephew is recalling 32 units of R3 Constrained Liners because the locking groove is oversized, which may prevent the locking ring from engaging properly.

    Product
    R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision…
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2015-06-17

    Smith & Nephew Recalls R3 Constrained Liner Due to Sizing Defect

    Smith & Nephew is recalling 17 units of the R3 Constrained Liner because the locking groove is oversized, potentially preventing the locking ring from engaging.

    Product
    R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision…
    Category
    Distribution
    11 states
  • SevereFDA (Devices)··2015-06-17

    Smith & Nephew Recalls R3 Constrained Liner Due to Sizing Defect

    Smith & Nephew is recalling R3 Constrained Liners because the locking groove is oversized, which may prevent the locking ring from engaging properly.

    Product
    R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision…
    Category
    Distribution
    11 states