International Medical Devices Database

Manufacturer Address
ACell, Inc, 8671 Robert Fulton Drive, Suite B, Columbia MD 21046-2582
Manufacturer Parent Company (2017)
Acell Inc.
Source
USFDA
1 Event
- Recall of Device Recall MatriStem Plastic Surgery Matrix XS,

One device in the database

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

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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ACell, Inc

One device in the database

Device Recall MatriStem Plastic Surgery Matrix XS,