FDA Device

Flexgard, off-the-shelf knee brace, product number 14761106

Hazard

Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.

What You Should Do

Remedy

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.

Products

Flexgard, off-the-shelf knee brace, product number 14761106
Brand
De Royal Industries
UPC
Product number 14761106, Lot numbers: 53078 and 53985

Units Affected

13