Recall Z-0713-2017 ยท IQI Orthosis, Limb Brace
DeRoyal Industries Inc
PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
| Date | Nov 7, 2016 |
| Status | Terminated |
| Reason | DeRoyal received complaints of mold on Tennis Elbow Straps. |
| Root cause | Under Investigation by firm |
| Action | DeRoyal issued their recall on 11/7/16 to the physician / clinician level by sending recall letters to its direct accounts and sales representatives. The foreign customer was notified by email on 11/7/2016. The customers were asked to identify the affected products, destroy them and return the provided notice of destruction form to DeRoyal for credit. |
| Quantity | 791 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.