The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1512-2021·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural failure (failed rivet) that compromises the medical function of the device (arm immobilization), posing a risk of harm if the arm is not properly supported, although no specific injuries are reported in the source text.

Plain-English summary

DJ Orthopedics de Mexico S.A. de C.V. is recalling the Donjoy Ultrasling Pro ER/IR 15 arm slings. The recall is due to a failed rivet at the chafe tab of the arm sling. This defect may prevent the device from properly immobilizing the arm as intended for medical purposes.

The affected product is the Donjoy Ultrasling Pro ER/IR 15, Universal, which is prescription-only. The recall includes units with lot numbers 2021-01-05, 2021-01-07, 2021-01-20, 2021-02-05, 2021-03-09, 2021-03-10, 2021-03-13, 2021-03-16, 2021-03-17, and 2021-03-18. The product was distributed worldwide, including the United States, Canada, France, Germany, Japan, Poland, and the United Kingdom.

Consumers and healthcare providers should stop using the affected arm slings and contact DJ Orthopedics for instructions on how to return or replace the product. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

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.
Manufacturer
DJ Orthopedics de Mexico S.A. de C.V.
Category
Medical Device — Orthopedic Support
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Lot Numbers:2021-01-05
  • 2021-01-07
  • 2021-01-20
  • 2021-02-05
  • 2021-03-09
  • 2021-03-10
  • 2021-03-13
  • 2021-03-16
  • 2021-03-17
  • 2021-03-18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by DJ Orthopedics de Mexico S.A. de C.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · DJ Orthopedics de Mexico S.A. de C.V.

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Same hazard · structural failure

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