Recalls / —

—#178137

Product

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

FDA product code

ITQ — Joint, Knee, External Brace

Device class

Class 1

Medical specialty

Physical Medicine

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

DeRoyal Industries Inc

Address

200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern

Nationwide, Australia, India, Saudi Arabia

Timeline

Recall initiated

2019-11-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #178137. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.