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Recall Observatory FDA recall evidence

Device product

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

Z-0706-2020

November 21, 2019

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 84364
Status
Ongoing
Classification
Class II
Quantity
2789 units
Official record key
device-enforcement:Z-0706-2020

Official wording

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

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

Distribution pattern: Nationwide, Australia, India, Saudi Arabia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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