Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1511-2021·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 may fail. The recall covers units distributed in the US and several international countries.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a mechanical defect (failed rivet) without reporting any injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

DJ Orthopedics de Mexico S.A. de C.V. is recalling the Donjoy Ultrasling Pro, 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 due to a failed rivet at the chafe tab of the arm sling.

The affected units were distributed worldwide, including the United States, Canada, France, Germany, Japan, Poland, and the United Kingdom. The recall includes specific lot numbers ranging from November 17, 2020, to March 19, 2021. The product is identified by the UDI (01)00190446673552.

Consumers should check their arm slings for the affected lot numbers. If the product is affected, they should stop using it and contact the recalling firm for instructions on return or replacement.

The recalled product

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

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 (20)

Lot Numbers: 2020-11-17
2020-11-28
2020-11-29
2020-11-30
2020-12-02
2020-12-07
2020-12-09
2020-12-10
2020-12-11
2020-12-12
2020-12-13
2021-01-12
2021-01-13
2021-01-14
2021-01-15
2021-01-20
2021-02-02
2021-02-03
2021-02-04
2021-02-05

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 →

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

See all →

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Donjoy Ultrasling Pro Arm Sling Recalled for Failed Rivet
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Same hazard · mechanical failure