The Recall Desk

FDA (Devices) recall action 83884

OrthoPediatrics Corp recalled 2 products on 2019-11-06

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-11-06
Critical
0
Units
1,938

Why these products were recalled

Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

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

1–2 of 2

  • ModerateFDA (Devices)··2019-11-06

    OrthoPediatrics Recalls Adolescent Nail Attachment Bolts Due to Binding Risk

    OrthoPediatrics Corp is recalling 969 Adolescent Nail Attachment Bolts because binding between the bolt and nail may delay surgical procedures.

    Product
    Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical in
    Category
    Distribution
    22 states
  • ModerateFDA (Devices)··2019-11-06

    OrthoPediatrics Recalls Child Nail Attachment Bolts Due to Binding Risk

    OrthoPediatrics Corp is recalling 969 Child Nail Attachment Bolts because they may bind with the intramedullary nail, potentially delaying surgical procedures.

    Product
    Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instrume
    Category
    Distribution
    22 states