FDA recall Z-0706-2020

DeRoyal Industries Inc · Class II · device

Product

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

Nationwide, Australia, India, Saudi Arabia

Key facts

Status
Ongoing
Initiation date
2019-11-21
Report date
2019-12-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0706-2020