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U.S. Department of Health and Human Services

Class 2 Device Recall Gentrix Surgical Matrix Thick

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  Class 2 Device Recall Gentrix Surgical Matrix Thick see related information
Date Initiated by Firm February 14, 2019
Create Date March 21, 2019
Recall Status1 Terminated 3 on May 07, 2020
Recall Number Z-1032-2019
Recall Event ID 82228
510(K)Number K170763  
Product Classification Mesh, surgical - Product Code FTM
Product Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.
Code Information SN KN000087
Recalling Firm/
ACell, Inc
6640 Eli Whitney Dr Ste 200
Columbia MD 21046-2626
For Additional Information Contact Thomas Gilbert PhD
410-715-1700 Ext. 8509
Manufacturer Reason
for Recall
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Urgent Medical Device Recall notification letters dated 2/14/19 were sent to customers.
Quantity in Commerce 1
Distribution US nationwide distribution in the state of CA.
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 and Original Applicant = ACell, Inc.