XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 1161928
This recall has been terminated (originally issued March 2, 2011).
- Recall Initiated
- January 7, 2011
- Posted
- March 2, 2011
- Terminated
- October 31, 2013
- Recall Number
- Z-1381-2011
- Quantity
- 1393 units
- Firm Location
- Warwick, RI
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
Lot numbers begin with the following 4 letters: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ
Root Cause
Process control
Action Taken
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.
More recalls by Davol, Inc., Sub. C. R. Bard, Inc.
Bard Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog Number: 59500...
Nov 1, 2011
Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010.
The Bard Soft Mesh patch is a non...
May 23, 2011
BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\
Catalog #0010302,
lot...
May 2, 2011