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U.S. Department of Health and Human Services

Class 2 Device Recall MatriStem Plastic Surgery Matrix XS,

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  Class 2 Device Recall MatriStem Plastic Surgery Matrix XS, see related information
Date Initiated by Firm July 07, 2011
Date Posted July 21, 2011
Recall Status1 Terminated 3 on October 21, 2011
Recall Number Z-2855-2011
Recall Event ID 59291
Product Classification Surgical Mesh - Product Code FTM
Product MatriStem¿ Plastic Surgery Matrix XS

Intended for implantation to reinforce tissue where weakness exists in urological, gynecological, and gastrointestinal anatomy, including, but not limited to the following procedures: pubourethral support, tissue repair, body wall repair, and esophageal repair
Code Information Model Numbers: PSMX0710, PSMX2025, PSMX1020, PSMX2030, PSMX1620, PSMX3030, PSMX2020, and PSMX3040 LOTS: OM004-802 OM021-802 OM058-801 OM068-805 OM005-802 OM023-802 OM061-808 OM070-81 OM006-801 OM023-803 OM063-81 OM071-807 OM014-802 OM026-802 OM064-81 OM075-805 OM014-805 OM033-804 OM064-801 OM076-805 OM015-803 OM047-807 OM065-808 OM088-804 OM020-802 OM052-808 OM067-803 OM098-804
Recalling Firm/
Manufacturer		 ACell, Inc
8671 Robert Fulton Drive
Suite B
Columbia MD 21046-2582
For Additional Information Contact Jennifer Bosley
410-953-8508
Manufacturer Reason
for Recall		 Surgical mesh for implantation may have elevated endotoxin levels.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action ACELL, Inc. sent an "Urgent: Medical Device Safety Alert" letter dated July 07, 2011 to all affected customers. The letter notified customers (physicians) of the possibility of elevated endotoxin levels in the product and affected lots. They were instructed to monitor their patients receiving the affected implants. For additional information please contact the Director of Regulatory Affairs & Quality Assurance at (410) 953-8508.
Quantity in Commerce 30 units
Distribution Nationwide (USA) Distribution including the states of CA, CT, FL, ID, IL, MD, MI, MS, NC, NJ, NV, NY, OH, OR, PA, TX and VA
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.
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