Z-1183-2023 Class II Ongoing
FDA device recall Z-1183-2023 was initiated by Covidien, LP on January 11, 2023 and is designated Class II. Reason for recall: 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 The recall status is ongoing. Affected quantity: 53 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2023
- Initiation Date
- January 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53 units
Product Description
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 for Recall
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
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.
Code Information
GTIN: A8845211784602 Lot Number: PVE0194M