Recall Z-0461-2019 ยท FTL Mesh, Surgical, Polymeric
Covidien LLC
Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side of the design is completely covered with the hydrophilic film. On the opposite side, only the two-dimensional central band i
| Date | Oct 5, 2018 |
| Status | Terminated |
| Reason | The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product failure led to hernia recurrence requiring additional surgical treatment. Symptoms of hernia recurrence may include discomfort, localized pain-free or painful bulging, and possible changes in the overlying skin. Medtronic has received, worldwide, a total of ten reports of mesh failure following use of the product in the last five years. Patients who have received a |
| Root cause | Unknown/Undetermined by firm |
| Action | On October 5, 2018, the firm notified its customers of the product issue via Urgent Medical Device Voluntary Removal. Required Actions: 1. Please quarantine and discontinue use of the affected item codes. 2. Complete the Product Return Form even if you do not have inventory. If no inventory, fax to 203-492-7719 or email FCAMITG@covidien.com. 3. If purchased directly from Medtronic, fax the return form to 800-895-6140 or email feedback.customerservice@covidien.com. Ship affected product with RGA# provided by customer service to: Medtronic Attn: Field Returns Department 195 McDermott Road No |
| Quantity | 7333 |
| Distribution | Worldwide distribution--US Nationwide |
| FDA record | Open on fda.gov |