The Recall Desk

FDA (Devices) recall action 74053

Synthes (USA) Products LLC recalled 3 products on 2016-06-15

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2016-06-15
Critical
0
Units
55

Why these products were recalled

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

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

1–3 of 3

  • ModerateFDA (Devices)··2016-06-15

    Synthes Rapid Resorbable Orbital Floor Plate Recalled for Labeling Errors

    Synthes (USA) Products LLC is recalling 19 units of 1.5 mm Rapid Resorbable Orbital Floor Plates due to potential expiration date discrepancies on outer packaging labels.

    Product
    1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatr
    Category
    Distribution
    16 states
  • ModerateFDA (Devices)··2016-06-15

    Synthes Recalls 22 Rapid Resorbable Orbital Floor Plates Due to Labeling Errors

    Synthes (USA) Products LLC is recalling 22 units of 1.5 mm Rapid Resorbable Orbital Floor Plates because outer package expiration dates may exceed subcomponent dates.

    Product
    1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pedia
    Category
    Distribution
    16 states
  • ModerateFDA (Devices)··2016-06-15

    Synthes Recalls 1.5 mm Rapid Resorbable Orbital Floor Plates Due to Labeling Errors

    Synthes (USA) Products LLC is recalling 14 units of 1.5 mm Rapid Resorbable Orbital Floor Plates because outer package expiration dates may exceed subcomponent dates.

    Product
    1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatr
    Category
    Distribution
    16 states