XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 1161928
FDA Recall Z-1381-2011 · Posted 2011-03-02
Recalling FirmDavol, Inc., Sub. C. R. Bard, Inc.
Recall StatusTerminated
Product CodeFTM
Date Initiated2011-01-07
Date Terminated2013-10-31
Product Quantity1393 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.