Recall Z-0706-2020 ยท ITQ Joint, Knee, External Brace
DeRoyal Industries Inc
DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
| Date | Nov 21, 2019 |
| Status | Open, Classified |
| Reason | The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking. |
| Root cause | 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 | 2789 units |
| Distribution | Nationwide, Australia, India, Saudi Arabia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.