The Recall Desk

FDA (Devices) recall action 74283

Synthes (USA) Products LLC recalled 7 products on 2016-07-20

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2016-07-20
Critical
0
Units
136,484,908

Why these products were recalled

Labeling does not match the cleared indications for use in the United States and Canada.

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

1–7 of 7

  • ModerateFDA (Devices)··2016-07-20

    Synthes 6.5 mm Cannulated Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 6.5 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in…
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2016-07-20

    Synthes Recalls 7.0 mm and 7.3 mm Cannulated Screws for Labeling Errors

    Synthes (USA) Products LLC is recalling 7.0 mm and 7.3 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to…
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2016-07-20

    Synthes Recalls 3.5 mm and 4.0 mm Cannulated Screws for Labeling Errors

    Synthes (USA) Products LLC is recalling 3.5 mm and 4.0 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to…
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2016-07-20

    Synthes 6.5 mm Cancellous Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 6.5 mm Cancellous Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in…
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2016-07-20

    Synthes 4.5 mm Cortex Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 4.5 mm Cortex Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar…
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2016-07-20

    Synthes Recalls 4.5 mm Cannulated Screws Due to Labeling Errors

    Synthes (USA) Products LLC is recalling 4.5 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to…
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2016-07-20

    Synthes 4.0 mm Cortex Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 4.0 mm Cortex Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS…
    Category
    Distribution
    51 states