The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1513-2021·Announced 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.

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 and involves a structural defect (failed rivet) in a medical device intended for immobilization, which poses a risk of harm if the device fails to support the arm, 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 REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY arm sling. The recall is due to a failed rivet at the chafe tab of the arm sling. The device is intended for medical purposes to immobilize the arm by means of a fabric band suspended from around the neck.

The affected lot numbers are 2021-01-05 and 2021-01-20. The products were distributed worldwide, including in the United States, Canada, France, Germany, Japan, Poland, and the United Kingdom. The FDA has classified this recall as Class II.

Consumers should stop using the affected arm slings and contact the manufacturer for further instructions.

The recalled product

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.
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 (2)

  • Lot Numbers: 2021-01-05
  • 2021-01-20

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 →

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

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