The Recall Desk

FDA (Devices) recall action 87727

DJ Orthopedics de Mexico S.A. de C.V. recalled 4 products on 2021-05-05

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
2021-05-05
Critical
0
Units
—

Why these products were recalled

failed rivet at the chafe tab of arm sling.

The agency’s own wording, quoted from the enforcement report.

1–4 of 4

  • HighFDA (Devices)··2021-05-05

    DJ Orthopedics Recalls Ultrasling Pro Arm Sling Due to Failed Rivet

    DJ Orthopedics is recalling Ultrasling Pro arm slings because a rivet at the chafe tab failed. The defect could compromise the device's ability to immobilize the arm.

    Product
    DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-05-05

    Donjoy Ultrasling Pro AB Arm Sling Recalled for Failed Rivet

    DJ Orthopedics is recalling Donjoy Ultrasling Pro AB arm slings due to a failed rivet at the chafe tab.

    Product
    DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-05-05

    Donjoy Ultrasling Pro Arm Sling Recalled for Failed Rivet

    DJ Orthopedics is recalling Donjoy Ultrasling Pro arm slings because a rivet at the chafe tab may fail. The recall covers units distributed in the US and several international countries.

    Product
    DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-05-05

    Donjoy Ultrasling Pro Arm Sling Recalled for Failed Rivet

    DJ Orthopedics is recalling Donjoy Ultrasling Pro arm slings because a rivet at the chafe tab failed, potentially compromising the device's ability to immobilize the arm.

    Product
    DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Distribution
    0 states