Device product
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
Z-1183-2023
Product summary
- Firm
- Covidien, LP
- Event
- Event 91567
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 53 units
- Official record key
device-enforcement:Z-1183-2023
Official wording
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
Code information: GTIN: A8845211784602 Lot Number: PVE0194M
Distribution pattern: 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.
Derived failure modes
-
Unknown
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