Recall Z-1183-2023 ยท FTL Mesh, Surgical, Polymeric
Covidien, LP
Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3
| Date | Feb 27, 2023 (initiated Jan 11, 2023) |
| Status | Open, Classified |
| Reason | Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant |
| Root cause | Under Investigation by firm |
| Action | Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" letter on Jan 11, 2023, to Risk Manager/Healthcare Professional/Distributor via UPS 2-day delivery. For outside United States. OUS countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and actions to take: Identify and quarantine all unused and non-expired product from the affected lot (PVE0194M) of Parietex" Composite Mesh. If Parietex" Composite Mesh with collagen film on the wrong side is encountered in the operating room setting, please discard the product and use additional, |
| Quantity | 53 units |
| Distribution | US Distribution to states of: CA, GA, NY and OUS Foreign distribution to countries of: Armenia, Belgium, France, Germany, Israel, Japan, Luxembourg, Romania, Spain, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PC Sofradim Production, Mar 9, 2018 |