Z-2243-2023 Class II Ongoing
FDA device recall Z-2243-2023 was initiated by Davol, Inc. on April 25, 2023 and is designated Class II. Reason for recall: Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, … The recall status is ongoing. Affected quantity: 169 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2023
- Initiation Date
- April 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 169 units
Product Description
Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU only)
Reason for Recall
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, India, Hong Kong, Greece, Chile, and Colombia.
Code Information
UDI-DI: (01)00801741201950(17)240528(10) Lot Number HUGT1609