Home / Recalls / Davol, Inc. / Z-2243-2023

Z-2243-2023 Class II Ongoing

Recalled by Davol, Inc. — Warwick, RI

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

Other recalls by Davol, Inc.

  • Z-2242-2023 Class II — Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, p (April 25, 2023)
  • Z-2244-2023 Class II — Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, per (April 25, 2023)
  • Z-2241-2023 Class II — Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460 (April 25, 2023)
  • Z-1457-2022 Class II — X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System (June 27, 2022)
  • Z-1304-2022 Class II — HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve (June 7, 2022)
  • Z-1305-2022 Class II — HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve (June 7, 2022)