Recall Z-0706-2020
DeRoyal Industries Inc · initiated November 21, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
Codes / 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
Reason for recall
The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0706-2020
- Initiated
- November 21, 2019
- Product code
- ITQ – Joint, Knee, External Brace
- Quantity
- 2789 units
- Distribution
- Nationwide, Australia, India, Saudi Arabia
- Recalling firm
- DeRoyal Industries Inc, Powell, TN