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Open, Classified

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

FDA Recall Z-0706-2020 · Posted None

Recalling FirmDeRoyal Industries Inc
Recall StatusOpen, Classified
Product CodeITQ
Date Initiated2019-11-21
Product Quantity2789 units

Reason for Recall

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

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Nationwide, Australia, India, Saudi Arabia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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