Z-1382-2011

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

Name: Z-1382-2011 XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #: 1161935
Creator: Davol, Inc., Sub. C. R. Bard, Inc.
Published: 2011-01-07
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2011-01-07 / Terminated / root cause: manufacturing process

FDA source

Davol, Inc., Sub. C. R. Bard, Inc. began a recall of XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #: 1161935 on 2011-01-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1382-2011
Status: Terminated
Initiated: 2011-01-07
Posted: 2011-03-02
Terminated: 2013-10-31
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #: 1161935
Product code: FTM Mesh, Surgical
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 886 units
Distribution: Nationwide
Product codes and lots: Lot numbers begin with the following 4 letters: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ

Product code FTM

K081272Class IIPorcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC / cleared 2008-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)