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Class 1 Device Recall XenMatrix Surgical Graft |
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Date Initiated by Firm |
January 07, 2011 |
Date Posted |
March 02, 2011 |
Recall Status1 |
Terminated 3 on October 31, 2013 |
Recall Number |
Z-1382-2011 |
Recall Event ID |
57566 |
510(K)Number |
K081272
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Product Classification |
Surgical Graft - Product Code FTM
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Product |
XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #: 1161935 |
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
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For Additional Information Contact |
SAME 401-825-8633
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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.
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FDA Determined Cause 2 |
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 |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FTM and Original Applicant = BRENNEN MEDICAL, LLC
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