Device product
Ventralight ST 4.5" Circle with Echo PS- 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: 5955450
Z-2242-2023
Product summary
- Firm
- Davol, Inc.
- Event
- Event 92213
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1599 units
- Official record key
device-enforcement:Z-2242-2023
Official wording
Reason: 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
Code information: UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: Lot Number HUGS0922 HUGS2026 HUGS2061 HUGS2020 HUGS2044 HUGS2015 HUGS2076 HUGT1582 HUGU0750 HUGU0748
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.
Derived failure modes
-
Unknown
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