Z-0706-2020Class II

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

Name: Z-0706-2020 DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
Creator: DeRoyal Industries Inc
Published: 2019-11-21
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2019-11-21 / Open, Classified / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP on 2019-11-21. FDA classified it as Class II and gives the reason as "The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0706-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-11-21
Posted: 2019-12-19
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
Product code: ITQ Joint, Knee, External Brace
Reason for recall: The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DeRoyal issued their recall on 11/21/19 by email and letter to the end user level by sending recall letters to its direct accounts. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested. Distributors were asked to further notify their customers. They were asked to do this directly or to provide us with a customer listing and we would notify them.
Quantity in commerce: 2789 units
Distribution: Nationwide, Australia, India, Saudi Arabia
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0706-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0706-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-25	2019-12-19

Product code ITQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)