The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1514-2021·Announced 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.

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 involves a structural defect (failed rivet) in a medical device intended to immobilize an arm, which poses a risk of harm if the device fails, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

DJ Orthopedics de Mexico S.A. de C.V. is recalling the Donjoy Ultrasling Pro AB, Universal, Rx Only arm sling. The product is intended for medical purposes to immobilize the arm by means of a fabric band suspended from around the neck.

The recall is being conducted because of a failed rivet at the chafe tab of the arm sling. The affected lot numbers are 2021-01-05, 2021-01-20, 2021-03-10, 2021-03-11, and 2021-03-16.

The product was distributed worldwide, including in the United States, Canada, France, Germany, Japan, Poland, and the United Kingdom. Consumers should stop using the affected arm slings and contact the manufacturer for instructions on how to proceed.

The recalled product

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.
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 (5)

  • Lot Numbers: 2021-01-05
  • 2021-01-20
  • 2021-03-10
  • 2021-03-11
  • 2021-03-16

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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