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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal KNEE BRACE, WARRIOR RECOVERY

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  Class 2 Device Recall DeRoyal KNEE BRACE, WARRIOR RECOVERY see related information
Date Initiated by Firm November 21, 2019
Create Date December 19, 2019
Recall Status1 Open3, Classified
Recall Number Z-0706-2020
Recall Event ID 84364
Product Classification Joint, knee, external brace - Product Code ITQ
Product DeRoyal KNEE BRACE, WARRIOR RECOVERY:
1) REF KB9000-01
2) REF 11-450A-00
3) REF 1150UTPP
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
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact customer service
888-938-7828
Manufacturer Reason
for Recall		 The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 2789 units
Distribution Nationwide, Australia, India, Saudi Arabia
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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