Agency classClass IIOur severity:High FDA (Devices)·Z-0706-2020·Announced 2019-12-25

DeRoyal Warrior Recovery Knee Brace Recalled for Hinge Breakage Risk

DeRoyal Industries is recalling Warrior Recovery Knee Braces because the hinge may break, causing the brace to come apart.

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 the hazard involves a structural defect (hinge breaking) that poses a risk of harm to the user, fitting the criteria for a High severity score where injury has not yet been reported.

Plain-English summary

DeRoyal Industries Inc is recalling the Warrior Recovery Knee Brace due to a potential safety hazard. The recall involves 2,789 units of the product, identified by reference numbers KB9000-01, 11-450A-00, and 1150UTPP, along with specific lot numbers listed in the agency's structured data.

The recall is being issued because the knee brace has the potential to come apart due to the hinge breaking. This defect could compromise the structural integrity of the device while in use.

The affected products were distributed nationwide in the United States, as well as in Australia, India, and Saudi Arabia. Consumers who possess these specific knee braces should stop using them and contact DeRoyal Industries Inc for further instructions on how to proceed with the recall.

The recalled product

Product: DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
Manufacturer: DeRoyal Industries Inc
Category: Medical Device — Orthopedic Support
Hazard: structural-failure
pinch-injury
Affected units: 2,789

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)

1) REF KB9000-01 Lot Numbers: 9798560
49798543
49976101
49798578
49976119
50166762
50166842
50353058
50353066
50353074
50353082
50353091
50353103
50471126
50575494
50555223 2) REF 11-450A-00 Lot Numbers: 9798480
50226649
50226665
49832318
49976047

Distribution

Distributed nationwide across the United States.

Same manufacturer · DeRoyal Industries Inc

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