Events

Recall of Device Recall MatriStem Plastic Surgery Matrix XS,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ACell, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59291
  • Event Risk Class
    Class 2
  • Event Number
    Z-2855-2011
  • Event Initiated Date
    2011-07-07
  • Event Date Posted
    2011-07-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102136
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Surgical Mesh - Product Code FTM
  • Reason
    Surgical mesh for implantation may have elevated endotoxin levels.
  • 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.

Device

Device Recall MatriStem Plastic Surgery Matrix XS,
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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
  • Product Description
    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
  • Manufacturer
    ACell, Inc

Manufacturer

ACell, Inc
  • Manufacturer Address
    ACell, Inc, 8671 Robert Fulton Drive, Suite B, Columbia MD 21046-2582
  • Manufacturer Parent Company (2017)
    Acell Inc.
  • Source
    USFDA