Recall Z-0658-03 ยท ITQ Joint, Knee, External Brace
De Royal Industries
Flexgard, off-the-shelf knee brace, product number 14761106
| Date | Mar 19, 2003 (initiated Feb 14, 2003) |
| Status | Terminated |
| Reason | Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use. |
| Root cause | Other |
| Action | The firm notified its consignees by letter dated 2/19/2003 asking them to return any in-stock product and to contact their consignees if the product was further distributed. |
| Quantity | 13 |
| Distribution | ID, CA, NC, TX, SC, NM, GA and TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.