Davol, Inc.: 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 tiss

Hazard

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

Details from the source

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: 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. Quantity: N/A Lot/code info: UDI-DI: (01)00801741201967(17)240428(10) Lot Number HUGS2043 HUGT1988

UPC codes

00801741201967

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.