U.S. Food and Drug Administration recently issued the following announcement.
Date Initiated by Firm: February 14, 2019
Create Date: March 21, 2019
Recall Status: Open, Classified
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/Manufacturer: 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: 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
Original source can be found here.
