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Terminated

XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #: 1161935

FDA Recall Z-1382-2011 · 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 Quantity886 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.

K081272PORCINE SURGICAL MESH; DERMAL MATRIXBrennen Medical, LLC · 2008-07-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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