Z-2244-2023 Class II Ongoing
FDA device recall Z-2244-2023 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: N/A.
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
- N/A
Product Description
Ventralight ST w EchoPS 4"x6" Ellipse- 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: 5955460G (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)00801741201967(17)240428(10) Lot Number HUGS2043 HUGT1988