The Recall Desk

FDA (Devices) recall action 85837

OrthoPediatrics Corp recalled 2 products on 2020-07-15

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
2020-07-15
Critical
0
Units
20

Why these products were recalled

ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.

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.

1–2 of 2

  • ModerateFDA (Devices)··2020-07-15

    OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors

    OrthoPediatrics Corp is recalling 11 units of ShieldLoc 7mm implant components because some packages contain the wrong size product.

    Product
    OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-07-15

    OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors

    OrthoPediatrics Corp is recalling 9 units of ShieldLoc 6mm implant components because some packages contain the wrong size.

    Product
    OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
    Category
    Distribution
    0 states