Z-0706-2020 Class II Ongoing
FDA device recall Z-0706-2020 was initiated by DeRoyal Industries Inc on November 21, 2019 and is designated Class II. Reason for recall: The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking. The recall status is ongoing. Affected quantity: 2789 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- November 21, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2789 units
Product Description
DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
Reason for Recall
The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
Distribution Pattern
Nationwide, Australia, India, Saudi Arabia
Code Information
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