Class 1 Device Recall XenMatrix Surgical Graft

• Date Initiated by Firm: January 07, 2011
• Date Posted: March 02, 2011
• Recall Status: Terminated on October 31, 2013
• Recall Number: Z-1381-2011
• Recall Event ID: 57566
• 510(K)Number: K081272
• Product Classification: Surgical Graft - Product Code FTM
• Product: XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 1161928
• Code Information: Lot numbers begin with the following 4 letters: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ
• Recalling Firm/ Manufacturer: Davol, Inc., Sub. C. R. Bard, Inc.; 100 Crossings Blvd; Warwick RI 02886-2850
• For Additional Information Contact: SAME; 401-825-8633
• Manufacturer 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.
• FDA Determined 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: 1393 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FTM