CLASS II ONGOING Device recall · Reported 25 Dec 2019 · FDA Enforcement Report

DeRoyal Knee Brace, Warrior Recovery recalled by DeRoyal Industries

DeRoyal Industries is recalling DeRoyal Knee Brace, Warrior Recovery, distributed nationwide in the US. The recall was initiated on 21 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 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, 50034962, 49976063, 49976071, 50167028, 50167052, 50166949, 50343909, 50353023, 50353031, 50353040, 50429112, 50465800, 50465797, 50555258, 50653675 3) REF 1150UTPP Lot Numbers: 49799386, 49843130, 49910865, 49976645, 49976637, 50166447, 50343870, 50352952, 50352961, 50352979, 50352987, 50352995, 50385594

Quantity recalled2789 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0706-2020
FDA event ID: 84364
Recalling firm: DeRoyal Industries, Powell, TN
Classification: Class II
Status: Ongoing
Recall initiated: 21 Nov 2019
FDA classified: 19 Dec 2019
Reported: 25 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

21 Nov 2019	Recall initiated by company
19 Dec 2019	Classified by FDA	+28 days
25 Dec 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP

Where it was distributed

Nationwide, Australia, India, Saudi Arabia

Nationwide

Questions about this recall

Is DeRoyal Knee Brace, Warrior Recovery recalled?

Yes. DeRoyal Industries recalled DeRoyal Knee Brace, Warrior Recovery on 21 Nov 2019. The recall is Class II and its status is Ongoing. Recall number Z-0706-2020.

Why was it recalled?

The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.

Which lots are affected?

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, 50034962, 49976063, 49976071, 50167028, 50167052, 50166949, 50343909, 50353023, 50353031, 50353040, 50429112, 50465800, 50465797, 50555258, 50653675 3) REF 1150UTPP Lot Numbers: 49799386, 49843130, 49910865, 49976645, 49976637, 50166447, 50343870, 50352952, 50352961, 50352979, 50352987, 50352995, 50385594

Where was it sold?

Nationwide, Australia, India, Saudi Arabia

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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