FDA Device

XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 10 x 15 cm Rectangle Catalog #: 1161015

Hazard

Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria.

What You Should Do

Remedy

Davol issued recall notification to accounts by letter dated 1/06/11 requesting recalled units be returned. contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product to Davol. A fax sheet attached to the letter to be completed and fax to 1-401-825-8753.

Products

XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 10 x 15 cm Rectangle Catalog #: 1161015
Brand
Davol, Inc., Sub. C. R. Bard, Inc.
UPC
Lot numbers begin with the following 4 letters:  HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ

Units Affected

1456 units