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Terminated

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

FDA Recall Z-2855-2011 · Posted 2011-07-21

Recalling FirmACell, Inc
Recall StatusTerminated
Product CodeFTM
Date Initiated2011-07-07
Date Terminated2011-10-21
Product Quantity30 units

Reason for Recall

Surgical mesh for implantation may have elevated endotoxin levels.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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