The Recall Desk

FDA (Devices) recall action 62525

Smith & Nephew, Inc. Endoscopy Division recalled 4 products on 2012-08-15

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2012-08-15
Critical
0
Units
12,189

Why these products were recalled

Distal part of the anchor may break on insertion into bone during surgery

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.

1–4 of 4

  • HighFDA (Devices)··2012-08-15

    Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Potential Breakage

    Smith & Nephew is recalling 2,204 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.

    Product
    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-08-15

    Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Breakage Risk

    Smith & Nephew is recalling 4,661 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.

    Product
    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intended for use for the reattachment of soft tissue to bone
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2012-08-15

    Smith & Nephew TWINFIX Ultra Ti Suture Anchor Recall for Breakage Risk

    Smith & Nephew is recalling 913 units of TWINFIX Ultra Ti Suture Anchors because the distal part may break during insertion into bone.

    Product
    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2012-08-15

    Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Breakage Risk

    Smith & Nephew is recalling 4,411 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.

    Product
    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone
    Category
    Distribution
    0 states