medical Class II Updated 2023-08-02

Davol, Inc. recalls Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, biores

Recalled Product

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)


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: (01)00801741201967(17)240428(10) Lot Number HUGS2043 HUGT1988
View official government recall

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