Recall Z-2855-2011 ยท FTM Mesh, Surgical
ACell, Inc
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
| Date | Jul 21, 2011 (initiated Jul 7, 2011) |
| Status | Terminated |
| Reason | Surgical mesh for implantation may have elevated endotoxin levels. |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.