Recall archive / FDA device enforcement
Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended ... — FDA record Z-1183-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 11, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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
- Classification
- Class II
- Recalling firm
- Covidien, LP
- Quantity
- 53 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1183-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN: A8845211784602 Lot Number: PVE0194M |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 8, 2023
- Recall initiation date
- Jan 11, 2023
- Center classification date
- Feb 26, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.