Z-2855-2011

MatriStem Plastic Surgery Matrix XS Intended for implantation to reinforce tissue where weakness exists in...

Name: Z-2855-2011 MatriStem Plastic Surgery Matrix XS Intended for implantation to reinforce tissue where weakness exists in...
Creator: ACell, Inc
Published: 2011-07-07
License: https://open.fda.gov/license/

ACell, Inc / initiated 2011-07-07 / Terminated / root cause: manufacturing process

FDA source

ACell, Inc began a recall of MatriStem Plastic Surgery Matrix XS Intended for implantation to reinforce tissue where weakness exists in urological, gynecological, and gastrointestinal... on 2011-07-07. The reason FDA records is "Surgical mesh for implantation may have elevated endotoxin levels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2855-2011
Status: Terminated
Initiated: 2011-07-07
Posted: 2011-07-21
Terminated: 2011-10-21
Recalling firm: ACell, Inc
Product: 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
Product code: FTM Mesh, Surgical
Reason for recall: Surgical mesh for implantation may have elevated endotoxin levels.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 30 units
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 codes and lots: 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 code FTM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)