Porcine Surgical Mesh; Dermal Matrix

• 4 recalls, same reason

  • Terminated Z-1379-2011 FDA Unclassified (pre-2012) ·initiated 7 Jan 2011
  • Terminated Z-1381-2011 FDA Unclassified (pre-2012) ·initiated 7 Jan 2011
  • Terminated Z-1380-2011 FDA Unclassified (pre-2012) ·initiated 7 Jan 2011
  • Terminated Z-1382-2011 FDA Unclassified (pre-2012) ·initiated 7 Jan 2011

  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.

510(k) Number

K081272 ↗

FDA Product Code

FTM

Models / Variants

Porcine Surgical Mesh

Dermal Matrix

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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